Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03018366
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000568', 'term': 'Amenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D011374', 'term': 'Progesterone'}], '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'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shufelt.chrisandra@mayo.edu', 'phone': '904-953-7224', 'title': 'Dr. Chrisandra Shufelt', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For the length of the study enrollment, 14 weeks.', 'eventGroups': [{'id': 'EG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product\n\n17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nProgesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill\n\nTransdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nPlacebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12 on trial', 'description': 'Change in PAT measured as reactive hyperemia index (RHI) from baseline to week 12 on treatment or placebo. Reactive hyperemia index (RHI) is the post-to-pre occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone of the occluded arm calculated by taking the ratio of the pulse amplitude during the hyperemic phase (after a period of blood flow occlusion) to the baseline pulse amplitude. The values below \\<1.67 are abnormal and suggest impaired endothelial function or endothelial dysfunction.', 'unitOfMeasure': 'change of RHI', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results represent the change (delta) in RHI after 12 week of treatment vs placebo'}, {'type': 'SECONDARY', 'title': 'Serum Inflammatory Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-4.57', 'upperLimit': '1.70'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change in serum cortisol from baseline to week 12 on treatment or placebo', 'description': 'Change in serum cortisol from baseline to week 12 on treatment or placebo', 'unitOfMeasure': 'µg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Estradiol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product\n\n17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nProgesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill\n\nTransdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nPlacebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.0', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '165.0'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '51.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Serum estradiol levels after 12 week of treatment vs placebo', 'description': 'Week 12 serum estradiol levels', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life (Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks'}], 'classes': [{'title': 'SF12-PCS', 'categories': [{'measurements': [{'value': '2.14', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': 'SF12-MCS', 'categories': [{'measurements': [{'value': '1.83', 'spread': '11.66', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '5.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in quality of life scores after 12 week of treatment vs placebo', 'description': 'Short-Form Health Survey 12 (SF-12) was reported as the mental component score (MCS) and physical component score (PCS). Each scale ranges from 0 to 100. For both PCS and MCS, higher values represent better outcomes, indicating superior physical or mental health, respectively. Lower scores suggest poorer outcomes in the respective domains. Scores above 50 for either PCS or MCS are generally considered above the population average for health-related quality of life, as the scales are often normed to a mean of 50 with a standard deviation of 10 in general population studies. Scores below 50 suggest below-average physical or mental health, with the degree of deviation providing further insight into the severity of physical or mental health challenges.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results represent the change (delta) in quality of life scores after 12 week of treatment vs placebo for MCS and PCS.'}, {'type': 'SECONDARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.67', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in PHQ-9 Scores after 12 week of treatment vs placebo', 'description': 'Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating greater severity of depressive symptoms.\n\nInterpretation of Scores:\n\n* 0-4: Minimal or no depression\n* 5-9: Mild depression\n* 10-14: Moderate depression\n* 15-19: Moderately severe depression\n* 20-27: Severe depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results report the change (delta) in PHQ-9 after 12 week of estrogen treatment vs placebo.'}, {'type': 'SECONDARY', 'title': 'Change in Insomnia Severity Index After 12 Week of Treatment vs Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Insomnia score after 12 week of treatment vs placebo', 'description': 'Change in Insomnia Severity Index after 12 week of treatment vs placebo. Insomnia Severity Index (ISI) total score ranges from 0 to 28.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results report the change (delta) of the insomnia severity index after 12 week of estrogen treatment vs placebo'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in Anxiety Scores after 12 week of treatment vs placebo', 'description': 'Overall Anxiety Severity and Impairment Scale (OASIS) total score ranges from 0 to 20, with each of the 5 items scored on a scale of 0 (no anxiety or impairment) to 4 (extreme anxiety or impairment). Higher scores indicate greater severity and functional impairment related to anxiety.\n\nThe OASIS scores can be categorized as follows:\n\n* 0-4: Minimal or no anxiety\n* 5-9: Mild anxiety\n* 10-14: Moderate anxiety with some functional impairment\n* 15-20: Severe anxiety with significant functional impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results report the change (delta) in Anxiety Scores after 12 week of estrogen treatment vs placebo'}, {'type': 'SECONDARY', 'title': 'Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.49', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '3.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in stress scores after 12 week of treatment vs placebo', 'description': 'Cohen Perceived Stress Scale (PSS) ranges from 0 to 40, with each of the 10 items scored on a scale of 0 (never) to 4 (very often). Higher scores reflect higher levels of perceived stress.\n\nThe PSS scores can be categorized as follows:\n\n* 0-13: Low perceived stress\n* 14-26: Moderate perceived stress\n* 27-40: High perceived stress', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Our results indicate the change (delta) in stress scores after 12 week of estrogen treatment vs placebo.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Estradiol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product\n\n17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nProgesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill\n\nTransdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nPlacebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '44.3', 'upperLimit': '144.8'}, {'value': '-4.7', 'groupId': 'OG001', 'lowerLimit': '-14.6', 'upperLimit': '4.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'change in estradiol after 12 week of treatment vs placebo', 'description': 'Change from Baseline to week 12 serum estradiol levels', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Inflammatory Markers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product'}, {'id': 'OG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0857', 'groupId': 'OG000', 'lowerLimit': '0.017', 'upperLimit': '0.174'}, {'value': '0.0322', 'groupId': 'OG001', 'lowerLimit': '-0.00021', 'upperLimit': '0.172'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change in serum hsCRP from baseline to week 12 on treatment or placebo', 'description': 'Change in serum hsCRP from baseline to week 12 on treatment or placebo', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product\n\n17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nProgesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.'}, {'id': 'FG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill\n\nTransdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nPlacebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product\n\n17beta Estradiol: Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nProgesterone: After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.'}, {'id': 'BG001', 'title': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill\n\nTransdermal placebo patch: Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nPlacebo Pill: After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '6.1', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '21.4', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '21.5', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist', 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '27.1', 'spread': '2.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hip', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '34.4', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '34.2', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at Menarche', 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '1.8', 'groupId': 'BG000'}, {'value': '12.9', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '12.96', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Estradiol', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '42'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '38'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '18.5', 'upperLimit': '35'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-03', 'size': 271124, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-19T12:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'dispFirstSubmitDate': '2024-01-24', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2016-12-01', 'resultsFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2017-01-10', 'dispFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-20', 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry', 'timeFrame': 'Baseline, week 12 on trial', 'description': 'Change in PAT measured as reactive hyperemia index (RHI) from baseline to week 12 on treatment or placebo. Reactive hyperemia index (RHI) is the post-to-pre occlusion PAT signal ratio in the occluded arm, relative to the same ratio in the control arm, corrected for baseline vascular tone of the occluded arm calculated by taking the ratio of the pulse amplitude during the hyperemic phase (after a period of blood flow occlusion) to the baseline pulse amplitude. The values below \\<1.67 are abnormal and suggest impaired endothelial function or endothelial dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Serum Inflammatory Markers', 'timeFrame': 'Change in serum cortisol from baseline to week 12 on treatment or placebo', 'description': 'Change in serum cortisol from baseline to week 12 on treatment or placebo'}, {'measure': 'Serum Estradiol Levels', 'timeFrame': 'Serum estradiol levels after 12 week of treatment vs placebo', 'description': 'Week 12 serum estradiol levels'}, {'measure': 'Quality of Life (Questionnaire)', 'timeFrame': 'Change in quality of life scores after 12 week of treatment vs placebo', 'description': 'Short-Form Health Survey 12 (SF-12) was reported as the mental component score (MCS) and physical component score (PCS). Each scale ranges from 0 to 100. For both PCS and MCS, higher values represent better outcomes, indicating superior physical or mental health, respectively. Lower scores suggest poorer outcomes in the respective domains. Scores above 50 for either PCS or MCS are generally considered above the population average for health-related quality of life, as the scales are often normed to a mean of 50 with a standard deviation of 10 in general population studies. Scores below 50 suggest below-average physical or mental health, with the degree of deviation providing further insight into the severity of physical or mental health challenges.'}, {'measure': 'Depression', 'timeFrame': 'Change in PHQ-9 Scores after 12 week of treatment vs placebo', 'description': 'Patient Health Questionnaire (PHQ-9) total score ranges from 0 to 27. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating greater severity of depressive symptoms.\n\nInterpretation of Scores:\n\n* 0-4: Minimal or no depression\n* 5-9: Mild depression\n* 10-14: Moderate depression\n* 15-19: Moderately severe depression\n* 20-27: Severe depression'}, {'measure': 'Change in Insomnia Severity Index After 12 Week of Treatment vs Placebo', 'timeFrame': 'Insomnia score after 12 week of treatment vs placebo', 'description': 'Change in Insomnia Severity Index after 12 week of treatment vs placebo. Insomnia Severity Index (ISI) total score ranges from 0 to 28.'}, {'measure': 'Anxiety', 'timeFrame': 'Change in Anxiety Scores after 12 week of treatment vs placebo', 'description': 'Overall Anxiety Severity and Impairment Scale (OASIS) total score ranges from 0 to 20, with each of the 5 items scored on a scale of 0 (no anxiety or impairment) to 4 (extreme anxiety or impairment). Higher scores indicate greater severity and functional impairment related to anxiety.\n\nThe OASIS scores can be categorized as follows:\n\n* 0-4: Minimal or no anxiety\n* 5-9: Mild anxiety\n* 10-14: Moderate anxiety with some functional impairment\n* 15-20: Severe anxiety with significant functional impairment.'}, {'measure': 'Stress', 'timeFrame': 'Change in stress scores after 12 week of treatment vs placebo', 'description': 'Cohen Perceived Stress Scale (PSS) ranges from 0 to 40, with each of the 10 items scored on a scale of 0 (never) to 4 (very often). Higher scores reflect higher levels of perceived stress.\n\nThe PSS scores can be categorized as follows:\n\n* 0-13: Low perceived stress\n* 14-26: Moderate perceived stress\n* 27-40: High perceived stress'}, {'measure': 'Change in Serum Estradiol Levels', 'timeFrame': 'change in estradiol after 12 week of treatment vs placebo', 'description': 'Change from Baseline to week 12 serum estradiol levels'}, {'measure': 'Serum Inflammatory Markers', 'timeFrame': 'Change in serum hsCRP from baseline to week 12 on treatment or placebo', 'description': 'Change in serum hsCRP from baseline to week 12 on treatment or placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['estrogen', 'premenopause', 'menopause', 'amenorrhea'], 'conditions': ['Estrogen Deficiency', 'Cardiovascular Disease (CVD)', 'Functional Hypothalamic Amenorrhea', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '37610989', 'type': 'DERIVED', 'citation': 'Shufelt CL, Saadedine M, Cook-Wiens G, Pisarska MD, Manson JE, Berga SL, Arditi M, Shah PK, Bairey Merz CN. Functional Hypothalamic Amenorrhea and Preclinical Cardiovascular Disease. J Clin Endocrinol Metab. 2023 Dec 21;109(1):e51-e57. doi: 10.1210/clinem/dgad498.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether young women with functional hypothalamic amenorrhea (premenopausal HypoE) is associated with risk factors for pre-clinical cardiovascular disease (CVD).\n\nFor this study, the investigators will measuring vascular function and inflammatory markers on:\n\n* young women with functional hypothalamic amenorrhea (\\>3 months of no menstrual cycle due to low estrogen)\n* young women with regular menstrual cycles not on hormone therapy.\n* recently menopausal women (\\<3 years from final menstrual period) not on hormone therapy.\n\nPremenopausal HypoE participants (women with functional hypothalamic amenorrhea) will be randomized to use either an estrogen patch or a placebo patch (no active medicine) for 12 weeks, followed by estrogen or placebo patch plus progesterone or placebo pills for 2 additional weeks. The investigators are looking to see if estrogen improves vascular and inflammation.', 'detailedDescription': 'Study Aims:\n\n1. To test the hypothesis premenopausal HypoE (women with FHA) is associated with pre-clinical CVD as determined by reductions in vascular endothelial function.\n2. To test the hypothesis premenopausal HypoE (women with FHA) is associated with increased immune-mediated inflammation.\n3. To test the hypothesis whether estrogen replacement can reduce inflammation and improve vascular endothelial function in premenopausal HypoE women (women with FHA).\n\nIn a randomized, double-blind placebo-controlled trial in premenopausal HypoE women (women with FHA) the investigators will test 12 weeks of transdermal estradiol 0.1 mg/day patch or placebo followed by 2 weeks of estradiol plus progesterone 200mg (for endometrial safety) on vascular endothelial function and immune-mediated inflammation versus placebo. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.\n\nThe investigators will be using non-invasive tests to measure vascular function to measures reactive hyperemic index (RHI) using peripheral arterial tonometry (PAT)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor premenopausal Hypo E and normal control women, inclusions include:\n\n* Premenopausal currently not on hormone therapy,\n* English speaking (for the purposes of complete psychosocial assessment)\n* able to give informed consent\n* a gynecological age (age since menarche) \\> 10 and \\< 25 years, and chronological age \\> 18 years\n* Within 90-110% of ideal body weight as determined by the 1983 Metropolitan Height and weight table for women\n* All participants with hypothalamic amenorrhea will be diagnosed based on exclusion of other etiologies for their amenorrhea, including pregnancy, thyroid dysfunction, hyperprolactinemia, premature ovarian insufficiency, and polycystic ovary disease\n\nFor recently menopausal women inclusions include:\n\n* Follicle stimulating hormones (FSH) \\>30 and 12 months of amenorrhea, within 3 years of final menstrual period with natural menopausal not on hormone therapy\n* English speaking\n* Able to give informed consent\n* Within 90-110% of ideal body weight\n\nExclusion Criteria:\n\nFor premenopausal Hypo E and normal control women exclusions include:\n\n* Smoking\n* Hypertension\n* Hyperlipidemia\n* Diabetes\n* Medications including psychotropic or illicit drugs, medical, neurological\n* Ophthalmologic disease except acuity problems\n* Major Axis I disorder other than depression\n* Pregnancy in the last 12 months and/or lactating in the last 6 months\n* Current use of hormone contraceptive or any estrogen or progestin therapy\n\nFor HypoE women, exclusion criteria include:\n\n\\- Allergy to adhesive or tape\n\nFor recently menopausal women exclusions also include:\n\n* Previous or current use of hormone therapy, estrogen or progestin\n* Surgical or chemotherapy induced menopause\n* Premature ovarian failure'}, 'identificationModule': {'nctId': 'NCT03018366', 'briefTitle': 'Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women', 'orgStudyIdInfo': {'id': 'PRO26081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '17Beta Estradiol, Progesterone', 'description': '17Beta Estradiol (0.1mg/day) , Progesterone (100mg) or Medroxyprogesterone (10mg) for patient with a peanut allergy because progesterone 100mg is a peanut based product', 'interventionNames': ['Drug: 17beta Estradiol', 'Drug: Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Transdermal Placebo Patch, Placebo Pill', 'description': 'Placebo Transdermal Patch, Placebo Pill', 'interventionNames': ['Drug: Transdermal placebo patch', 'Drug: Placebo Pill']}], 'interventions': [{'name': '17beta Estradiol', 'type': 'DRUG', 'otherNames': ['Estradiol Transdermal Patch', 'Vivelle-Dot'], 'description': 'Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.', 'armGroupLabels': ['17Beta Estradiol, Progesterone']}, {'name': 'Transdermal placebo patch', 'type': 'DRUG', 'description': 'Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.', 'armGroupLabels': ['Transdermal Placebo Patch, Placebo Pill']}, {'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Prometrium'], 'description': 'After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.', 'armGroupLabels': ['17Beta Estradiol, Progesterone']}, {'name': 'Placebo Pill', 'type': 'DRUG', 'otherNames': ['Placebo Oral Pill'], 'description': 'After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.', 'armGroupLabels': ['Transdermal Placebo Patch, Placebo Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Cedars-Sinai Barbra Streisand Women's Heart Center", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Chrisandra Shufelt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Noel Bairey-Merz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Division of General Internal Medicine', 'investigatorFullName': 'Chrisandra Shufelt', 'investigatorAffiliation': 'Mayo Clinic'}}}}