Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-22 @ 6:12 AM
Study NCT ID:
NCT02516202
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Vaginal Health Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004414', 'term': 'Dyspareunia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'C000654104', 'term': 'segesterone acetate and ethinyl estradiol vaginal system'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kguthrie@fredhutch.org', 'phone': '2066675595', 'title': 'Dr. Katherine A. Guthrie', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for each participant from randomization through the 12-week visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.", 'otherNumAtRisk': 99, 'deathsNumAtRisk': 102, 'otherNumAffected': 26, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form.", 'otherNumAtRisk': 99, 'deathsNumAtRisk': 100, 'otherNumAffected': 22, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form.", 'otherNumAtRisk': 99, 'deathsNumAtRisk': 100, 'otherNumAffected': 24, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Increased vaginal secretions', 'notes': 'Counted in participants who did not report moderate-severe vaginal secretions at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 14}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal itching', 'notes': 'Counted in participants who did not report moderate-severe vaginal itching at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 84, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast tenderness', 'notes': 'Counted in participants who did not report moderate-severe breast tenderness at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal spotting or bleeding', 'notes': 'Counted in participants who did not report moderate-severe vaginal spotting or bleeding at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash outside the vagina', 'notes': 'Counted in participants who did not report moderate-severe skin rash outside the vagina at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body rash', 'notes': 'Counted in participants who did not report moderate-severe body rash at baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization for dehydration', 'notes': 'Admitted to hospital for ongoing gastrointestinal symptoms. Admitted again 6 days later with dehydration diagnosis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'notes': 'Lobular carcinoma in left breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphoma', 'notes': 'Lymphoma confirmed by lab tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'notes': 'Infiltrating ductal carcinoma left breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for back pain', 'notes': 'Participant reported increasing back pain, worsening spinal stenosis, required surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Most Bothersome Symptom (MBS) Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'title': 'Week 4 minus baseline', 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '-1.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.8'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '0.1'}]}]}, {'title': 'Week 12 minus baseline', 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-1.2'}, {'value': '-1.2', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-1.0'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '-1.1'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}, {'pValue': '0.31', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants with MBS data at baseline and either week 4 or 12.'}, {'type': 'SECONDARY', 'title': 'Vaginal Symptoms Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'title': 'Week 4 minus baseline', 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}]}]}, {'title': 'Week 12 minus baseline', 'categories': [{'measurements': [{'value': '-0.9', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '-0.8'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.6'}, {'value': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '-0.7'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}, {'pValue': '0.05', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Mean change from baseline to 12 weeks in composite Vaginal Symptoms Index (VSI).\n\nThe VSI is a Modified Bachman scale measuring vulvovaginal itching, dryness, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants with VSI data at baseline and either week 4 or 12.'}, {'type': 'SECONDARY', 'title': 'Female Sexual Function Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'title': 'Week 4 minus baseline', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.7'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.1'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '4.7'}]}]}, {'title': 'Week 12 minus baseline', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.9'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '4.5'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '6.1'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress. A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '3.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Likert Scale 0 = no to 10 = complete satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Benefit Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'p-value calculation includes 195 participants with known responses at week 12.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Patient Benefit Evaluation: Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'categories': [{'title': 'Week 12 pH > 5', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}, {'title': 'Week 12 pH ≤ 5', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.60', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Objective measures of genitourinary atrophy: pH (\\<5 or \\>5) at week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample includes 247 participants with pH \\> 5 at baseline and non-missing data on pH at week 12'}, {'type': 'SECONDARY', 'title': 'Vaginal Maturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'OG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'OG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'classes': [{'categories': [{'title': 'Week 12 VMI ≤ 5%', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}, {'title': 'Week 12 VMI > 5%', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Objective Measures of Genitourinary Atrophy: Vaginal Maturation Index (VMI) described by % parabasal, intermediate, and superficial cells (≤ 5% or \\>5% superficial cells) at week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample includes 223 participants with VMI ≤ 5% superficial cells at baseline and non-missing VMI data at week 12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'FG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'FG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Stopped Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo vaginal gel visually identical composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.\n\nVagifem: One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study."}, {'id': 'BG001', 'title': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel. 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo vaginal tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.\n\nReplens: 2.5 gm to be applied vaginally every 3 days over 12 weeks.\n\nPlacebo: Dispensed in visually identical bottle and tablet form."}, {'id': 'BG002', 'title': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo arm' of the study. This arm is comprised of two placebo preparations; placebo vaginal tablet and placebo vaginal gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo vaginal gel. The product is a inert hydroxyethylcellulose gel (pH adjusted).\n\nPlacebo: Dispensed in visually identical bottle and tablet form.\n\nPlacebo: Dispensed in visually identical tube and gel form."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61', 'spread': '4', 'groupId': 'BG000'}, {'value': '61', 'spread': '4', 'groupId': 'BG001'}, {'value': '61', 'spread': '4', 'groupId': 'BG002'}, {'value': '61', 'spread': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}, {'title': 'African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Other / unknown', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27', 'spread': '5', 'groupId': 'BG000'}, {'value': '26', 'spread': '4', 'groupId': 'BG001'}, {'value': '26', 'spread': '6', 'groupId': 'BG002'}, {'value': '26', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '6 participants have missing data on BMI'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'High school diploma / GED or less', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'School after high school', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': 'College graduate', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never married', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Divorced or widowed', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Married or like relationship', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}, {'title': 'Past', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}, {'title': 'Current', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': '0 drinks / week', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}, {'title': '1-6 drinks / week', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': '≥ 7 drinks / week', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Menopause Quality of Life Questionnaire total', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '3.3', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Menopause Quality of Life Questionnaire (MENQOL) is a series of 29 questions to assess quality of life in four domains: physical (16 questions), psychosocial (7), sexual (3), and vasomotor (3). Each domain includes occurrence and severity of symptoms; the item scores are averaged for a domain score ranging from 0 (no symptom) to 8 (maximum severity). The four domain scores are then averaged to calculate the total MENQOL score, ranging from 0 (high quality of life) to 8 (low quality of life).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '11 participants have missing data for MENQOL total'}, {'title': 'Patient Health Questionnaire 8 depression', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'None (0-4)', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}, {'title': 'Mild (5-9)', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Moderate - severe (≥10)', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Patient Health Questionnaire (PHQ-8) assesses severity of depression. There are 8 questions, each scored from 0 to 3, that are summed to create a total score ranging from 0 to 24. The scores are categorized as follows: minimal depression (0 to 4), mild depression (5 to 9), moderate depression (10 to 14), moderately severe depression (15 to 19), severe depression (20 to 24).', 'unitOfMeasure': 'Participants'}, {'title': 'Generalized Anxiety Disorder Questionnaire 7', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'None (0-4)', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}, {'title': 'Mild (5-9)', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Moderate - severe (≥10)', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Generalized Anxiety Disorder 7 (GAD-7) assesses generalized anxiety symptoms. It contains 7 questions, each scored from 0 to 3, that are summed to create a total score ranging from 0 to 21. The scores are categorized as follows: minimal GAD (0 to 4), mild GAD (5 to 9), moderate GAD (10 to 14), severe GAD (15 to 21).', 'unitOfMeasure': 'Participants'}, {'title': 'Sexually active', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Female Sexual Distress Scale-Revised, item 1, distressed about sex life', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never / rarely', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Occasionally', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}, {'title': 'Frequently / always', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Female Sexual Function Index total', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '539', 'groupId': 'BG000'}, {'value': '15.2', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '16.1', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '15.5', 'spread': '6.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Female Sexual Function Index (FSFI) assesses sexual functioning in women. It consists of 19 questions grouped into 6 domains: desire (2 questions), arousal (4), lubrication (4), orgasm (3), satisfaction (3), and pain (3). Each domain score ranges from a low value between 0 and 1.2 (varies by domain) and a high value of 6. The domain scores are summed to calculate the total FSFI score (range 2-36), with high scores indicating better sexual function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '50 participants have missing data on FSFI total'}, {'title': 'Vaginal pH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': '≤ 5', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': '> 5', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vaginal maturation index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': '≤ 5% superficial cells', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}]}, {'title': '> 5% superficial cells', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most bothersome symptom', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Vulvar and/or vaginal itching', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Vulvar and/or vaginal pain', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Vaginal dryness', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Vulvar and/or vaginal irritation', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Pain with vaginal penetration', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Self-reported health', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '302', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Excellent', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Very good', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}, {'title': 'Good', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Fair / poor', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-01', 'size': 13021680, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-05-01T15:38', 'hasProtocol': True}, {'date': '2016-11-01', 'size': 2377445, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-05-01T15:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2015-08-03', 'resultsFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-13', 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Most Bothersome Symptom (MBS) Severity', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.'}], 'secondaryOutcomes': [{'measure': 'Vaginal Symptoms Index', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Mean change from baseline to 12 weeks in composite Vaginal Symptoms Index (VSI).\n\nThe VSI is a Modified Bachman scale measuring vulvovaginal itching, dryness, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3.'}, {'measure': 'Female Sexual Function Index', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress. A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'Week 12', 'description': 'Likert Scale 0 = no to 10 = complete satisfaction.'}, {'measure': 'Patient Benefit Evaluation', 'timeFrame': 'Week 12', 'description': 'Patient Benefit Evaluation: Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).'}, {'measure': 'pH', 'timeFrame': 'Week 12', 'description': 'Objective measures of genitourinary atrophy: pH (\\<5 or \\>5) at week 12'}, {'measure': 'Vaginal Maturation Index', 'timeFrame': 'Week 12', 'description': 'Objective Measures of Genitourinary Atrophy: Vaginal Maturation Index (VMI) described by % parabasal, intermediate, and superficial cells (≤ 5% or \\>5% superficial cells) at week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrophy of Vagina', 'Menopause', 'Dyspareunia (Female)']}, 'referencesModule': {'references': [{'pmid': '37402281', 'type': 'DERIVED', 'citation': 'Mitchell CM, Larson JC, Reed SD, Guthrie KA. The complexity of genitourinary syndrome of menopause: number, severity, and frequency of vulvovaginal discomfort symptoms in women enrolled in a randomized trial evaluating treatment for genitourinary syndrome of menopause. Menopause. 2023 Aug 1;30(8):791-797. doi: 10.1097/GME.0000000000002212. Epub 2023 Jul 4.'}, {'pmid': '36374501', 'type': 'DERIVED', 'citation': 'Mitchell CM, Larson JC, Crandall CJ, Bhasin S, LaCroix AZ, Ensrud KE, Guthrie KA, Reed SD. Association of Vaginal Estradiol Tablet With Serum Estrogen Levels in Women Who Are Postmenopausal: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241743. doi: 10.1001/jamanetworkopen.2022.41743.'}, {'pmid': '35353163', 'type': 'DERIVED', 'citation': 'Srinivasan S, Hua X, Wu MC, Proll S, Valint DJ, Reed SD, Guthrie KA, LaCroix AZ, Larson JC, Pepin R, Bhasin S, Raftery D, Fredricks DN, Mitchell CM. Impact of Topical Interventions on the Vaginal Microbiota and Metabolome in Postmenopausal Women: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e225032. doi: 10.1001/jamanetworkopen.2022.5032.'}, {'pmid': '33675793', 'type': 'DERIVED', 'citation': 'Mitchell CM, Ma N, Mitchell AJ, Wu MC, Valint DJ, Proll S, Reed SD, Guthrie KA, Lacroix AZ, Larson JC, Pepin R, Raftery D, Fredricks DN, Srinivasan S. Association between postmenopausal vulvovaginal discomfort, vaginal microbiota, and mucosal inflammation. Am J Obstet Gynecol. 2021 Aug;225(2):159.e1-159.e15. doi: 10.1016/j.ajog.2021.02.034. Epub 2021 Mar 4.'}, {'pmid': '33367735', 'type': 'DERIVED', 'citation': 'Hudson PL, Ling W, Wu MC, Hayward MR, Mitchell AJ, Larson J, Guthrie KA, Reed SD, Kwon DS, Mitchell CM. Comparison of the Vaginal Microbiota in Postmenopausal Black and White Women. J Infect Dis. 2021 Dec 1;224(11):1945-1949. doi: 10.1093/infdis/jiaa780.'}, {'pmid': '30994576', 'type': 'DERIVED', 'citation': 'Mitchell CM, Guthrie KA, Larson J, Diem S, LaCroix AZ, Caan B, Shifren JL, Woods NF, Heiman JR, Lindau ST, Reed SD. Sexual frequency and pain in a randomized clinical trial of vaginal estradiol tablets, moisturizer, and placebo in postmenopausal women. Menopause. 2019 Aug;26(8):816-822. doi: 10.1097/GME.0000000000001341.'}, {'pmid': '29738424', 'type': 'DERIVED', 'citation': 'Diem SJ, Guthrie KA, Mitchell CM, Reed SD, Larson JC, Ensrud KE, LaCroix AZ. Effects of vaginal estradiol tablets and moisturizer on menopause-specific quality of life and mood in healthy postmenopausal women with vaginal symptoms: a randomized clinical trial. Menopause. 2018 Oct;25(10):1086-1093. doi: 10.1097/GME.0000000000001131.'}, {'pmid': '29554173', 'type': 'DERIVED', 'citation': 'Mitchell CM, Reed SD, Diem S, Larson JC, Newton KM, Ensrud KE, LaCroix AZ, Caan B, Guthrie KA. Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):681-690. doi: 10.1001/jamainternmed.2018.0116.'}], 'seeAlsoLinks': [{'url': 'http://www.fredhutch.org/en/labs/phs/projects/msflash.html', 'label': 'Fred Hutchinson Cancer Research Center website'}]}, 'descriptionModule': {'briefSummary': 'This is a new application from the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network. Here we propose to conduct a large multicenter trial comparing two common treatments, a vaginal hormone tablet and an over-the-counter gel, with placebo to evaluate their effects on bothersome vaginal symptoms and sexual function, and to create a biorepository of specimens for future translational, mechanistic research on the etiology of vaginal symptoms.', 'detailedDescription': 'The Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) Clinical Trials network was established in 2009. By the end of 2014, the network completed 4 clinical trials testing 7 interventions in approximately 1000 women ages 40-62 with vasomotor (VMS) and other menopause symptoms.\n\nThe current trial will evaluate a relatively understudied area of menopause - vaginal health and sexual function. This is a 3-arm, randomized, controlled, double-blind, clinical trial among postmenopausal women ages 45-70.\n\nOur primary aim is to evaluate the effectiveness of ultra-low dose vaginal estradiol (Vagifem 10 mcg), non-hormonal hydrophilic non-prescriptive vaginal gel (Replens) and placebo in reducing the Most Bothersome Symptom (MBS) severity. Choices for MBS include vulvovaginal itching, pain, dryness, irritation, or pain with penetration.\n\nSecondary aims include an evaluation of a composite score of vaginal symptoms, sexual function, treatment satisfaction, menopause quality of life, and objective measures of genitourinary atrophy. We will also create a biorepository of vaginal and blood specimens. In a subset of women, we will examine whether treatment response is related to: a) the post-menopausal vaginal microbiome; b) vaginal mucosal inflammation; and c) reproductive hormone profiles. The in-depth focus on the mechanisms associated with postmenopausal vaginal symptoms will use state of the art microbiologic techniques on longitudinally collected biologic specimens and will guide future translational studies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Females aged 45-70 years\n* 2 or more years since last natural menstrual period, or surgical menopause (bilateral oophorectomy)\n* At least 1 vaginal symptom (inside or outside the vagina) reported from the following list, experienced in the past 30 days which is moderate or severe:\n\n * Dryness at least once a week\n * Itching at least once a week\n * Irritation at least once a week\n * Soreness/Pain at least once a week\n * Pain associated with sexual activity at least once\n* Signed informed consent\n\nExclusion Criteria\n\n* Current unexplained abnormal genital bleeding (or any unevaluated bleeding since menopause)\n* Currently pregnant, attempting pregnancy or breast feeding\n* Current acute vaginal infection (as indicated by wet mount at V1)\n* Pelvic or vaginal surgery in prior 60 days\n* Antibiotic use in the past 30 days\n* Women under age 55 with endometrial ablation\n* Women under age 55 with hysterectomy and at least one ovary\n* Current cancer treatment (exception basal or squamous skin cell cancers)\n* Current or past thromboembolic disease (pulmonary embolus or deep vein thrombosis, not including thrombophlebitis), myocardial infarction or stroke\n* Current severe liver disease\n* Current or past breast or endometrial cancer or pre-cancer\n* Blood clotting disorder (e.g., Factor V Leiden, prothrombin mutation, protein C, protein or antithrombin deficiency)\n* Porphyria\n* Current or past lichen sclerosus or lichen planus\n* History of adverse reaction to vaginal estrogen or Replens\n* Use of any systemic reproductive hormones (hormonal contraception, postmenopausal hormone therapies, SERMS) in the past 2 months\n* Use of hormonal contraception in the past year\n* Use of any type of vaginal estrogen product (however interested women will be allowed to join the study if they abstain from use during the month preceding enrollment)\n* Use of any type of vaginal moisturizer, douche, vaginal prebiotic or probiotic, or soap in the vagina in the past month (however interested women will be allowed to join the study if they abstain from use during the month preceding enrollment)\n* Unwilling to abstain from use of any non-study vaginal moisturizer, vaginal estrogen, douche, or soap in the vagina throughout the trial\n* Unable to follow instructions, complete questionnaires, or physically unable to place product in the vagina\n* Current participation in another drug trial or intervention study\n* Chronic vulvo-vaginal symptoms in the 5 years before menopause (defined as a vaginal or vulvar condition requiring more than 4 visits to a health care provider in a given year)'}, 'identificationModule': {'nctId': 'NCT02516202', 'briefTitle': 'The Vaginal Health Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'The Vaginal Health Trial - Effects of Vaginal Estradiol Tablet and Moisturizing Gel on Postmenopausal Vaginal Symptoms', 'orgStudyIdInfo': {'id': 'MsFLASH 05'}, 'secondaryIdInfos': [{'id': '8378', 'type': 'OTHER', 'domain': 'FHCRC IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vagifem', 'description': "One hundred participants will be randomized into the Vagifem® 'active' arm. These women will receive a bottle of Vagifem® tablets (estradiol 10 mcg). One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.\n\nVagifem® tablets contain 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. The excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate. Vagifem® comes as a small white film-coated tablet. The coating is made of hypromellose and polyethylene glycol.\n\nA placebo gel visually similar to Replens composed of inert hydroxyethylcellulose gel (pH adjusted) applied every 3 days over entire 12 weeks.", 'interventionNames': ['Drug: Vagifem', 'Other: Placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Replens', 'description': "One hundred participants will be randomized into the Replens® 'active' arm. These women will receive a tube containing Replens® vaginal gel, with 2.5 gm applied vaginally every 3 days over 12 weeks.\n\nReplens® is a bioadhesive polycarbophil-based moisturizing vaginal gel containing; purified water (vehicle humectant), glycerin (moisturizer), mineral oil (as a moisturizer), polycarbophil and carbomer homopolymer type B (allow the product to stick to the vaginal wall), hydrogenated palm oil glyceride (moisturizer), sorbic acid (preservative, antimicrobial), methylparaben, sodium hydroxide (adjusts pH of product so it is suitable for vaginal use).\n\nA placebo tablet visually identical to Vagifem® is inserted daily for 2 weeks, then 2 days/week for remaining 10 weeks.", 'interventionNames': ['Device: Replens', 'Other: Placebo tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "One hundred participants will be randomized into the 'placebo' arm of the study. This arm is comprised of two placebo preparations; placebo tablet and placebo gel applied on the same schedule as 'active' arms.\n\nThe placebo tablet coating and excipient ingredients will be the same as are used for Vagifem®; the coating is made of hypromellose and polyethylene glycol and the excipient (inactive) ingredients are hypromellose, lactose monohydrate, maize starch, and magnesium stearate.\n\nPlacebo gel. The product is an inert hydroxyethylcellulose gel (pH adjusted).", 'interventionNames': ['Other: Placebo tablet', 'Other: Placebo gel']}], 'interventions': [{'name': 'Vagifem', 'type': 'DRUG', 'otherNames': ['vaginal estradiol'], 'description': 'One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.', 'armGroupLabels': ['Vagifem']}, {'name': 'Replens', 'type': 'DEVICE', 'otherNames': ['non-hormonal hydrophilic non-prescriptive vaginal gel'], 'description': '2.5 gm to be applied vaginally every 3 days over 12 weeks.', 'armGroupLabels': ['Replens']}, {'name': 'Placebo tablet', 'type': 'OTHER', 'description': 'Dispensed in visually identical bottle and tablet form to Vagifem.', 'armGroupLabels': ['Placebo', 'Replens']}, {'name': 'Placebo gel', 'type': 'OTHER', 'description': 'Dispensed in visually identical tube and gel form to Replens.', 'armGroupLabels': ['Placebo', 'Vagifem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente Washington Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Katherine A Guthrie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutchinson Cancer Center'}, {'name': 'Susan D Reed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Andrea Z LaCroix, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}, {'name': 'Caroline Mitchell, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'The MsFLASH Data Coordinating Center will perform the statistical analyses for the primary and secondary study results papers. Within a 12-month period after publication of the main study results, the Data Coordinating Center will prepare datasets for public release that include all data elements in the main publication with certain deletions and recoding to protect study subject confidentiality. The public release datasets will include substantial documentation in electronic form, thus allowing external investigators to independently analyze the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katherine Guthrie', 'investigatorAffiliation': 'Fred Hutchinson Cancer Center'}}}}