Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 4:07 AM
Study NCT ID:
NCT00117468
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2005-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D014622', 'term': 'Vaginal Creams, Foams, and Jellies'}, {'id': 'C400424', 'term': 'Crinone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2005-06-30', 'studyFirstSubmitQcDate': '2005-07-06', 'lastUpdatePostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate endometrial transformation', 'timeFrame': 'Cycle Day 25 or 26'}], 'secondaryOutcomes': [{'measure': 'Hormone levels', 'timeFrame': 'Duration of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['luteal phase replacement', 'oocyte donation', 'infertility', 'progesterone'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nlm.nih.gov/medlineplus/infertility.html', 'label': 'MedlinePlus - Infertility'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.', 'detailedDescription': 'This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months.\n\nLuteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not pregnant\n* Clinically or medically-induced non-functioning or surgically removed ovaries\n* Clinical investigator believes patient would be eligible for oocyte donation\n\nExclusion Criteria:\n\n* Any contraindication to progesterone or estrogen therapy\n* Undiagnosed vaginal bleeding\n* History of uterine fibroids or any other conditions that could adversely affect pregnancy success\n* Hysterectomy\n* Any contraindication to vaginal drug delivery systems'}, 'identificationModule': {'nctId': 'NCT00117468', 'briefTitle': 'Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement', 'orgStudyIdInfo': {'id': 'DR-PGN-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DR-2011']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Progesterone 8% Vaginal Gel']}], 'interventions': [{'name': 'DR-2011', 'type': 'DRUG', 'description': 'Administered vaginally from Day 14 to Day 31', 'armGroupLabels': ['1']}, {'name': 'Progesterone 8% Vaginal Gel', 'type': 'DRUG', 'otherNames': ['Crinone'], 'description': 'Administered vaginally from Cycle Day 14 to Day 31', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Duramed Protocol Chair', 'role': 'STUDY_CHAIR', 'affiliation': 'Duramed Research, Inc,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duramed Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Duramed Protocol Chair', 'oldOrganization': 'Duramed Research, Inc.'}}}}