Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-03 @ 7:03 AM
Study NCT ID:
NCT02026869
Status:
UNKNOWN
Last Update Posted:
2014-01-03
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Administration of Metformin in PCOS Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-02', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ovulation rates', 'timeFrame': '6 months', 'description': 'Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.'}], 'secondaryOutcomes': [{'measure': 'Therapeutic drug level', 'timeFrame': 'Over 24 hours after administration.', 'description': 'Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaginal administration, PCOS, Metformin'], 'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as metformin. Oral administration of metformin is accompanied by undesirable side effects. The vagina proved to be a good alternative to the oral route for other drugs. Using metformin through the vagina and avoidance of such side effects, while maintaining its effectiveness, would help women to better tolerate this drug.', 'detailedDescription': 'PCOS is the most common of all female endocrinopathies affecting 7-10% of women. A variety of drugs have been used to help improve follicular dynamics in PCOS patients. Metformin, an insulin sensitizer long known for its antidiabetic properties, has been used in PCOS patients. One of the major factors affecting compliance are the gastrointestinal side effects associated with oral administration of metformin. Knowing that the vagina is a good absorptive surface for many drugs, it is postulated that vaginal administration of metformin could be a good alternative to the oral route, if it proves effective. Both pharmacokinetic and clinical evidences of efficacy are traced for the vaginal route of administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with PCOS according to the Rotterdam criteria\n* age 20-35 years\n* not to have received any induction of ovulation in the preceding 3 months before enrollment\n\nExclusion Criteria:\n\n* contraindications to metformin\n* prior surgical management of PCOS'}, 'identificationModule': {'nctId': 'NCT02026869', 'acronym': 'VMPCO', 'briefTitle': 'Vaginal Administration of Metformin in PCOS Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Vaginal Administration of Metformin in Women With PCOS.', 'orgStudyIdInfo': {'id': 'Vaginal Metformin- Ahmed Nasr'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral metformin', 'description': 'Metformin 850 mg tablets taken by mouth every 12 hours for 6 months', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal metformin', 'description': 'Metformin 850 mg tablets taken vaginally every 12 hours for 6 months', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Cidophage'], 'description': 'Metformin is taken either orally or vaginally every 12 hours', 'armGroupLabels': ['Oral metformin', 'Vaginal metformin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71516', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': "Women's Health Hospital", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'AHMED NASR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Professor, Women's Health Hospital, Assiut University, Egypt."}, {'name': 'MAGDY AMIN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'AHMED NASR', 'investigatorAffiliation': 'Assiut University'}}}}