Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 8:09 AM
Study NCT ID:
NCT00698035
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2008-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}], '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': 'mmelisko@medicine.ucsf.edu', 'phone': '415-353-7070', 'title': 'Michelle Melisko, MD', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks', 'otherNumAtRisk': 39, 'otherNumAffected': 10, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment', 'otherNumAtRisk': 36, 'otherNumAffected': 10, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Facial hair growth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vaginal itching or irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vaginal odor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Serum Estradiol (E2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'OG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'title': 'E2 at baseline', 'categories': [{'measurements': [{'value': '27', 'spread': '36', 'groupId': 'OG000'}, {'value': '9', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'E2 at 4 weeks', 'categories': [{'measurements': [{'value': '5', 'spread': '5', 'groupId': 'OG000'}, {'value': '10', 'spread': '20', 'groupId': 'OG001'}]}]}, {'title': 'E2 at 12 weeks', 'categories': [{'measurements': [{'value': '9', 'spread': '12', 'groupId': 'OG000'}, {'value': '8', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, participants who completed 12 weeks of assigned treatment'}, {'type': 'SECONDARY', 'title': 'Matched E2 by Commercial and Research (RIA) Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E2 by LC/MS', 'description': 'A commercially available ultrasensitive E2 level was measured at baseline and 4 weeks (Quest Diagnostics, liquid chromatography tandem mass spectrometry (LC/MS, PM range \\<10 pg/ml)'}, {'id': 'OG001', 'title': 'E2 by RIA', 'description': 'Additional measurement of baseline and week 4 E2 by RIA'}], 'classes': [{'title': 'Baseline E2', 'categories': [{'measurements': [{'value': '17.7', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '44.1', 'groupId': 'OG001'}]}]}, {'title': '4-week E2', 'categories': [{'measurements': [{'value': '7.8', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Comparison of baseline estradiol between LC/MS and RIA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'singificant at p\\<0.05', 'groupDescription': 'Comparison of week 4 estradiol between LC/MS and RIA', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4 weeks', 'description': 'Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients from both study arms arms with matched pairs of baseline and week 4 E2 performed by both commercial and research labs'}, {'type': 'PRIMARY', 'title': 'Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'OG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \\>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \\>10 pg/dl, subsequent levels \\>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, to be considered evaluable for the Primary Outcome, patients must complete both baseline evaluation and week 4 safety blood draw. 1 participant in the Testosterone arm was not evaluable.'}, {'type': 'SECONDARY', 'title': 'Total Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'title': 'Testosterone at baseline', 'categories': [{'measurements': [{'value': '33', 'spread': '19', 'groupId': 'OG000'}]}]}, {'title': 'Testosterone at 4 weeks', 'categories': [{'measurements': [{'value': '186', 'spread': '276', 'groupId': 'OG000'}]}]}, {'title': 'Testosterone at 12 weeks', 'categories': [{'measurements': [{'value': '171', 'spread': '251', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'By serum ultrasensitive total testosterone test (Quest Diagnostics)', 'unitOfMeasure': 'ng/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, participants assigned to the Testosterone arm who completed 12 weeks of assigned treatment and had testosterone measurement at baseline, 4 weeks and 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Sexual Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'OG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'title': 'SI (BL)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'SI (W4)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'SI (W12)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'SD (BL)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'SD (W4)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'SD (W12)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SI from BL to W12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SD from BL to W12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0228', 'groupIds': ['OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SI from BL to W12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SD from BL to W12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided responses to SD, SI and SS at 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)'}, {'type': 'SECONDARY', 'title': 'Sexual Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'OG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'title': 'SS (BL)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'SS (W4)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'SS (W12)', 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SS from Baseline to Week 12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.139', 'groupIds': ['OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Change in SS from Baseline to Week 12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who provided responses to SD, SI and SS at all 3 time points: Baseline (BL), Week 4 (W4), and Week 12 (W12)'}, {'type': 'SECONDARY', 'title': 'Change in Vaginal Epithelium Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'OG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'classes': [{'title': 'Rugae', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Pallor', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Petechiae', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal thinning', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Dryness', 'categories': [{'measurements': [{'value': '-1.03', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0061', 'groupIds': ['OG001'], 'pValueComment': 'Significant at p\\<0.05', 'groupDescription': 'Difference in petechiae between baseline and week 12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with both baseline and week 12 gynecologic exams for evaluation of vaginal atrophy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'FG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Of 76 enrolled participants, one participant consented and was assigned to ESTRING, but did not insert ESTRING prior to withdrawing from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks'}, {'id': 'BG001', 'title': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '78'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '74'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Characteristics for 75 participants who initiated treatment. One participant consented and was assigned to ESTRING, but did not insert ESTRING prior to withdrawing from the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2008-06-11', 'resultsFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-27', 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range', 'timeFrame': '12 Weeks', 'description': 'Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \\>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \\>10 pg/dl, subsequent levels \\>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.'}], 'secondaryOutcomes': [{'measure': 'Serum Estradiol (E2)', 'timeFrame': '12 weeks', 'description': 'serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)'}, {'measure': 'Matched E2 by Commercial and Research (RIA) Analyses', 'timeFrame': 'baseline, 4 weeks', 'description': 'Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women'}, {'measure': 'Total Testosterone Levels', 'timeFrame': '12 weeks', 'description': 'By serum ultrasensitive total testosterone test (Quest Diagnostics)'}, {'measure': 'Sexual Quality of Life', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.'}, {'measure': 'Sexual Satisfaction', 'timeFrame': 'Baseline, Week 4, Week 12', 'description': 'Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).'}, {'measure': 'Change in Vaginal Epithelium Scores', 'timeFrame': 'Baseline, 12 weeks', 'description': 'During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaginal Testosterone Cream', 'ESTRING'], 'conditions': ['Sexual Dysfunction, Physiological']}, 'referencesModule': {'references': [{'pmid': '27832260', 'type': 'DERIVED', 'citation': 'Melisko ME, Goldman ME, Hwang J, De Luca A, Fang S, Esserman LJ, Chien AJ, Park JW, Rugo HS. Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2017 Mar 1;3(3):313-319. doi: 10.1001/jamaoncol.2016.3904.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.', 'detailedDescription': 'There is a growing body of scientific literature to suggest that sexual functioning is one of the most distressing problems experienced by breast cancer survivors. Vaginal dryness, dyspareunia (pain during sexual intercourse), and decreased libido are common complaints among breast cancer patients. With increasing use of aromatase inhibitors which are associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming even more prominent. This study will evaluate the safety and tolerability of the ESTRING and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed Stage I-III breast cancer who are taking an aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the aromatase inhibitor at least 60 days prior to enrolling.\n2. Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis.\n\n * Patient may be rendered postmenopausal through the use of a GnRH agonist, but must have confirmed post-menopausal levels of serum estradiol on two lab tests at least one month apart.\n * If patient has been rendered post-menopausal by adjuvant chemotherapy but has had a period within the past 12 months, post-menopausal levels of serum estradiol must be documented on two lab tests at least 3 months apart.\n3. Age ≥18 and ≤80 years old.\n4. ECOG ≤1\n5. Adequate hematologic, hepatic, and renal function as defined by:\n\n * Hgb ≥9 g/dL\n * Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3\n * Platelet count ≥100,000/mm3\n * Serum creatinine ≤1.5 mg/dL\n * Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the ULN\n6. Normal thyroid function tested within the past 6 months (Patients with a diagnosis of hypothyroidism and on thyroid supplementation must have had thyroid function tests in the normal range within the past 3 months)\n7. Patient must have recovered from the side effects of previous chemotherapy, surgery, or radiation therapy for early breast cancer.\n\nExclusion Criteria:\n\n1. History of radiation to the vaginal area\n2. Concurrent treatment with any type of oral, injectable or topical form of estrogen or androgen therapy including natural supplements marketed as hormone replacement products\n3. Initiation of topical moisturizers (for example, Replens), or herbal or alternative medicines to manage the symptoms of vaginal dryness while on study. Patients who were previously using these products may continue them with the same usage pattern while on study.\n4. Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens or androgens within the past 30 days.\n5. History of an abnormal pap smear within the last 12 months\n6. History of endometrial or ovarian cancer\n7. Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a gynecological exam and/or pelvic ultrasound\n8. History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual dysfunction will be defined as loss of libido or inability to achieve orgasm for which patient sought medical attention or which patient felt significantly interfered with quality of life.)\n9. Moderate or severe depression for which the patient is receiving ongoing psychological counseling and/or taking antidepressants, and for whom, in the investigators opinion may be interfering in the patients sexual function independent of the side effects of breast cancer and aromatase inhibitor use.\n10. Use of any investigational agent for breast cancer within 3 weeks of study entry.'}, 'identificationModule': {'nctId': 'NCT00698035', 'acronym': 'E-String', 'briefTitle': 'Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors', 'orgStudyIdInfo': {'id': 'UCSF-067519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone Cream', 'description': 'Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment', 'interventionNames': ['Drug: Testosterone Cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Estring', 'description': 'Estring 2mg ring inserted vaginally once every 12 weeks', 'interventionNames': ['Drug: Estring']}], 'interventions': [{'name': 'Testosterone Cream', 'type': 'DRUG', 'otherNames': ['intravaginal testosterone cream'], 'description': '1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment', 'armGroupLabels': ['Testosterone Cream']}, {'name': 'Estring', 'type': 'DRUG', 'otherNames': ['ESTRING Estrodial Vaginal Ring'], 'description': '2mg ring inserted vaginally once every 12 weeks', 'armGroupLabels': ['Estring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Michelle Melisko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}