Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 6:42 PM
Study NCT ID:
NCT00948857
Status:
TERMINATED
Last Update Posted:
2012-09-10
First Post:
2009-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ngleicher@thechr.com', 'phone': '212-994-4400', 'title': 'Dr. Norbert Gleicher', 'organization': 'Center for Human Reproduction'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Termination due to lack of consenting participants.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dehydroepiandrosterone 25 mg Tid po', 'description': 'Dehydroepiandrosterone 25 mg tid po', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Blinded Placebo', 'description': 'Blinded placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Live Birth', 'timeFrame': '24 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Endocrine Effects', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Androgen Side Effects', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Pregnancy', 'timeFrame': '12 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Live Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DHEA', 'description': 'Dehydroepiandrosterone 25 mg tid po'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Blinded placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'description': 'Live Birth outcome compared between DHEA active treatment and Placebo', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was closed for futility because of difficulty finding patients willing to undergo randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dehydroepiandrosterone 25 mg Tid po', 'description': 'Dehydroepiandrosterone 25 mg tid po'}, {'id': 'FG001', 'title': 'Blinded Placebo', 'description': 'Blinded placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 completed and 1 dropped out.', 'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dehydroepiandrosterone 25 mg Tid po', 'description': 'Dehydroepiandrosterone 25 mg tid po'}, {'id': 'BG001', 'title': 'Blinded Placebo', 'description': 'Blinded placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '3', 'groupId': 'BG000'}, {'value': '38', 'spread': '3', 'groupId': 'BG001'}, {'value': '38', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', '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': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-04', 'studyFirstSubmitDate': '2009-07-28', 'resultsFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Birth', 'timeFrame': '24 months'}, {'measure': 'Live Birth', 'timeFrame': '9 months', 'description': 'Live Birth outcome compared between DHEA active treatment and Placebo'}], 'secondaryOutcomes': [{'measure': 'Endocrine Effects', 'timeFrame': '12 months'}, {'measure': 'Androgen Side Effects', 'timeFrame': '12 months'}, {'measure': 'Clinical Pregnancy', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DHEA', 'POF', 'Pregnancy', 'Ovarian Failure', 'Otherwise Unexplained infertility', 'Ovarian aging'], 'conditions': ['Premature Ovarian Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.centerforhumanreprod.com/', 'label': 'Center for Human Reproduction'}]}, 'descriptionModule': {'briefSummary': 'The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with open tubes, fertile male partners and evidence of premature ovarian failure.', 'detailedDescription': 'Recruitment:\n\n* New patients presenting for Donor egg cycles\n* Possible print, magazine or Radio advertisement\n\nExperimental plan:\n\n1. Informed consent\n2. Baseline studies\n\n * Antral follicle counts\n * Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X\n3. Randomization\n\n * Group A: DHEA (25 mg three times per day)\n * Group B: Placebo\n4. Monitoring during treatment\n\n * All participants will have:\n * USG for follicle measurement\n * Repeat serum, FSH, E2, DHEA, DHEAS, testosterone, AMH monthly during treatment.\n * Physical examination\n * Completion of study questionnaire regarding possible androgen effects of treatment\n5. Analysis plan:\n\n * Primary Outcome\n * Pregnancy\n * Pregnancy rates will be compared using logistic regression with age and pre-treatment AMH as covariates.\n * Secondary Outcomes\n * Endocrine Factors\n * Androgen side effects\n * Primary analysis. We will perform a factorial ANOVA for the two pretreatment factors DHEA and Placebo. Baseline AMH and age as main covariates\n * Secondary analysis.\n * Examine rate of change of estradiol and other endocrine response over the four cycles of treatment\n * Compare antral follicle counts across cycles between groups\n * Compare possible androgen related effects\n * Power considerations:\n * Power assumptions: alpha 0.05; 80% power\n\nSpontaneous Pregnancy rate for POF is less than 1% per 3 months Intervention will improve pregnancy rate to 10% per 3 months. Patients will be treated for 3 cycles. Require 100 patients to complete treatment in each group. Allow for 20% dropout will need 120 patients randomized to each group\n\n* Randomization:\n\nRandomization will be by permuted blocks in order to maintain an even distribution among the groups (because of the small numbers of participants)\n\n* Human subjects issues\n* Potential risks associated with DHEA use\n* Potential risk of delay of treatment for 3 months and possible natural continued loss of fertility\n* Informed consent issues'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 1 year of infertility\n* \\>21 and \\<40 years old\n* Normal HSG\n* Normal Semen analysis (Count \\>= 20 million/ motility \\> 50%/ Kruger morph \\> 14%.\n* Absent menses\n* Willingness to sign informed consent for study randomization\n* Willingness to participate in 3 months of treatment.\n\nExclusion Criteria:\n\n* Abnormal semen analysis\n* Abnormal HSG\n* Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia\n* Family history of significant genetic disease, or factor V leiden thrombophilia\n* Inability to present for monitoring visits\n* Inability to follow medication instruction\n* Desire to undergo other fertility treatments before completing three months of this trial'}, 'identificationModule': {'nctId': 'NCT00948857', 'acronym': 'DHEAFert2', 'briefTitle': 'Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)', 'organization': {'class': 'OTHER', 'fullName': 'Center for Human Reproduction'}, 'officialTitle': 'A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).', 'orgStudyIdInfo': {'id': '092508-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHEA active treatment', 'description': 'Dehydroepiandrosterone 25 mg tid po', 'interventionNames': ['Dietary Supplement: Dehydroepiandrosterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DHEA Placebo', 'description': 'Blinded placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Dehydroepiandrosterone', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['DHEA'], 'description': '25 mg PO TID', 'armGroupLabels': ['DHEA active treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Blinded placebo', 'armGroupLabels': ['DHEA Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Human Reproduction', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Barad, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Human Reproduction'}, {'name': 'Norbert Gleicher, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Human Reproduction'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David H. Barad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'David H. Barad', 'investigatorAffiliation': 'Center for Human Reproduction'}}}}