Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-21 @ 6:54 PM
Study NCT ID:
NCT00474851
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077563', 'term': 'Norethindrone Acetate'}, {'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}], 'ancestors': [{'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Amy.DiVasta@childrens.harvard.edu', 'phone': '617-355-3792', 'title': 'Dr. Amy D. DiVasta', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Sample of skeletally mature young women; Measurements of aBMD are two-dimensional and do not yield information regarding skeletal strength or microarchitecture'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were evaluated every 3 months (at every research visit) for a total of 12 months (the duration of study participation).', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily', 'otherNumAtRisk': 25, 'otherNumAffected': 15, 'seriousNumAtRisk': 25, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Placebo group\n\nPlacebo: Placebo capsule 1 pill PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily', 'otherNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Myalgias/arthralgias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic pain', 'notes': 'Pain that did not require hospitalization or surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization for pelvic/abdominal pain', 'notes': "All events determined to be likely due to flare of subject's underlying disease, endometriosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'notes': 'Bone fractures, secondary to fall or trauma. Non spontaneous, not low impact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo group\n\nPlacebo: Placebo capsule 1 pill PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10', 'groupDescription': 'Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.\n\nThe primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA.', 'statisticalMethod': 'RMANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'description': 'Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Body Bone Mineral Content (BMC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo: Placebo capsule 1 pill PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '10', 'groupId': 'OG000'}, {'value': '15', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02', 'groupDescription': 'The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.\n\nThe primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA.', 'statisticalMethod': 'RMANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Placebo group\n\nPlacebo: Placebo capsule 1 pill PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Completed Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Placebo: Placebo capsule 1 pill PO daily\n\nNorethindrone acetate: Norethindrone acetate 5 mg PO daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '18.1', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', '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': '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2007-05-15', 'resultsFirstSubmitDate': '2015-03-04', 'studyFirstSubmitQcDate': '2007-05-15', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-17', 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Mineral Density', 'timeFrame': 'Baseline to 12 months', 'description': 'Adjusted mean change in total body areal bone mineral density (aBMD) over the 12 month trial'}], 'secondaryOutcomes': [{'measure': 'Total Body Bone Mineral Content (BMC)', 'timeFrame': 'Baseline to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometriosis', 'Adolescents', 'Bone density', 'GnRH Agonist', 'Add-back therapy'], 'conditions': ['Endometriosis']}, 'referencesModule': {'references': [{'pmid': '30454733', 'type': 'DERIVED', 'citation': 'Gallagher JS, DiVasta AD, Vitonis AF, Sarda V, Laufer MR, Missmer SA. The Impact of Endometriosis on Quality of Life in Adolescents. J Adolesc Health. 2018 Dec;63(6):766-772. doi: 10.1016/j.jadohealth.2018.06.027.'}, {'pmid': '26181088', 'type': 'DERIVED', 'citation': 'DiVasta AD, Feldman HA, Sadler Gallagher J, Stokes NA, Laufer MR, Hornstein MD, Gordon CM. Hormonal Add-Back Therapy for Females Treated With Gonadotropin-Releasing Hormone Agonist for Endometriosis: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):617-627. doi: 10.1097/AOG.0000000000000964.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a regimen of norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal health and quality of life in adolescents treated with a GnRH agonist for endometriosis.', 'detailedDescription': 'Endometriosis has become increasingly recognized as a chronic illness which begins during adolescence. Untreated endometriosis may lead to chronic pain and infertility. As recognition of the need for prompt therapy increases, so does the length of time patients will be exposed to treatments. As a result, there exists a pressing need to evaluate adjunctive measures that may limit the associated negative health consequences of treatment.\n\nA gonadotropin-releasing hormone (GnRH) agonist is one medication utilized for patients who have failed other treatments. While GnRH-agonists are effective in relieving symptoms, their long-term use is problematic. GnRH agonists induce a low-estrogen state, causing deleterious effects on bone mineralization. These negative consequences are especially important for our pediatric patients. Adolescence is the critical period in a woman\'s life for bone acquisition and attainment of peak bone mass. Anything that interferes with this process puts patients at risk for lifelong low bone density and future fracture.\n\n"Add-back" therapy appears to be a promising adjunct to treatment for prevention of this bone loss. Daily therapy with low-doses of hormones preserves bone density in adult patients, without altering the efficacy of the GnRH-agonist. However, no data exist on the effect of add-back therapy in adolescents.\n\nThe aim of the current study is to evaluate the safety and efficacy of two add-back regimens, norethindrone acetate + placebo or norethindrone acetate + conjugated estrogens, for the preservation of skeletal health and quality of life in adolescents with endometriosis treated with a GnRH-agonist.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 13-22 years, at least two years post-menarche\n* Body mass index (BMI, kg/m2) between 18 -30 kg/m2\n* Surgical diagnosis of endometriosis\n* Clinical decision to treat with a GnRH agonist, leuprolide depot (Lupron Depot®; TAP Pharmaceuticals, Inc.) 11.25 mg intra-muscular every 3 months\n\nExclusion Criteria:\n\n* Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, renal disease, or diabetes mellitus\n* Markedly impaired liver function or liver failure\n* Personal history of thromboembolic event (such as deep venous thrombosis)\n* Medication use known to affect bone metabolism:\n\n * Glucocorticoid therapy (including inhaled steroids) or anticonvulsants used in the last 6 months'}, 'identificationModule': {'nctId': 'NCT00474851', 'briefTitle': 'The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial', 'orgStudyIdInfo': {'id': '07-01-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norethindrone acetate + estrogens', 'description': 'Subjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + conjugated equine estrogens 0.625 mg by mouth daily for the 12 months of study participation.', 'interventionNames': ['Drug: Norethindrone acetate + estrogens']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'norethindrone acetate + placebo', 'description': 'Subjects randomized to the experimental arm received add-back therapy with norethindrone acetate 5 mg by mouth daily + a placebo capsule by mouth daily for the 12 months of study participation.', 'interventionNames': ['Drug: norethindrone acetate + placebo']}], 'interventions': [{'name': 'Norethindrone acetate + estrogens', 'type': 'DRUG', 'otherNames': ['Aygestin', 'Premarin'], 'description': 'Norethindrone acetate 5 mg by mouth daily + Conjugated equine estrogens 0.625 mg by mouth daily', 'armGroupLabels': ['Norethindrone acetate + estrogens']}, {'name': 'norethindrone acetate + placebo', 'type': 'DRUG', 'otherNames': ['Aygestin'], 'description': 'norethindrone acetate 5 mg by mouth daily + Placebo capsule 1 pill by mouth daily', 'armGroupLabels': ['norethindrone acetate + placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Amy D DiVasta, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amy DiVasta', 'investigatorAffiliation': "Boston Children's Hospital"}}}}