Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 12:33 AM
Study NCT ID:
NCT00005104
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-04-06', 'studyFirstSubmitQcDate': '2000-04-06', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-04-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['endocrine disorders', 'hyperinsulinism', 'polycystic ovarian syndrome', 'rare disease'], 'conditions': ['Polycystic Ovary Syndrome', 'Hyperinsulinism']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.', 'detailedDescription': 'PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.\n\nPatients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nPatients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate\n\nMust have oligoovulation and hyperandrogenemia\n\n--Prior/Concurrent Therapy--\n\nEndocrine therapy: At least 2 months since prior clomiphene citrate\n\nOther:\n\n* At least 2 months since prior standard therapy (including over the counter drugs)\n* At least 2 months since prior investigational drugs\n* Prior multi/prenatal vitamins allowed\n\n--Patient Characteristics--\n\nHematopoietic: Hematocrit greater than 38%\n\nHepatic:\n\n* Liver function normal\n* No clinically significant hepatic disease\n\nRenal:\n\n* No clinically significant renal disease\n* Creatinine less than 1.4 mg/dL\n* No proteinuria\n\nCardiovascular: No clinically significant cardiac disease\n\nPulmonary: No clinically significant pulmonary disease\n\nHormonal:\n\n* Thyroid function normal\n* Prolactin normal\n* Estradiol normal\n* Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency\n\nOther:\n\n* Not pregnant\n* Negative pregnancy test\n* Male partner must have a normal semen analysis by WHO criteria\n* Must be in acceptable health by interview, medical history, physical exam, and laboratory tests\n* No diabetes mellitus\n* No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease\n* No clinically significant malignant disease except nonmelanomatous skin cancer\n* At least 1 year since any prior drug abuse or alcoholism'}, 'identificationModule': {'nctId': 'NCT00005104', 'briefTitle': 'Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'orgStudyIdInfo': {'id': '199/14915'}, 'secondaryIdInfos': [{'id': 'UVA-HIC-7538'}, {'id': 'UVA-WSE026'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'clomiphene citrate', 'type': 'DRUG'}, {'name': 'metformin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University School of Medicine', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University - St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23298-0230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medical College of Virginia School of Medicine', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '40100', 'city': 'Bologna', 'country': 'Italy', 'facility': 'University Alma Mater', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'William S. Evans', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}]}}}