Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:59 AM
Study NCT ID:
NCT07459595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D007294', 'term': 'Inositol'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LH/FSH ratio', 'timeFrame': '3 Months', 'description': 'It will be assessed in terms of ratio between LH and FSH after 3 months of treatment.'}, {'measure': 'Regular cycles', 'timeFrame': '3 Months', 'description': 'It will be labeled if number of days from the start (day 1) of one period until the start (day 1) of the next period are almost equal for at least 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'Myo-inositol', 'Polycystic Ovarian Syndrome (PCOS)'], 'conditions': ['Polycystic Ovarian Syndrome (PCOS)']}, 'descriptionModule': {'briefSummary': 'In polycystic ovary syndrome (PCOS), changes in physical appearance i.e. weight gain, hirsutism, menstrual disturbances and infertility result in reduced quality-of-life. PCOS is one of the most common endocrine disorders affecting about 4% to 8% of women of reproductive age. Diagnosis is primarily clinical with Rotterdam criteria being the most commonly followed criteria, which require the presence of two out of the three criteria including oligo and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound.\n\nThe objective of this study is to compare the outcome of Metformin versus Myo-inositol in the management of polycystic ovarian disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Married or unmarried\n* Diagnosed with PCOS (females presenting with compliant of irregular cycle for \\>3 months, with hirsutism, acne, presence of polycystic ovaries detected on ultrasound ).\n\nExclusion Criteria:\n\n* Females already taken or taking PCOS treatment (on medical record)\n* Females already enrolled in another trial program\n* Females already taking trial drugs\n* Females with chronic diabetes (BSR\\>200 mg/dl), hypertension (BP≥140/90mmHg)\n* Females with PCOS along with gestational sac (on ultrasound)\n* Females allergic to any content of trial drugs (on history)'}, 'identificationModule': {'nctId': 'NCT07459595', 'briefTitle': 'Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Combined Military Hospital Gujranwala'}, 'officialTitle': 'Metformin Versus Myo-inositol in the Management of Polycystic Ovarian Disease: A Comparative Study', 'orgStudyIdInfo': {'id': '23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months', 'description': 'Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral myoinositol 1g twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma', 'interventionNames': ['Drug: Myoinositol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months', 'description': 'Informed consent will be obtained from each female. Demographic data (name, age, height and weight for BMI, duration of symptoms (irregular cycles from how many months), marital status, parity, residence, socioeconomic status, diet pattern, family history of PCOS, and life style will be recorded. Females will be asked for their menstrual cycle duration and irregularity. Females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months. All females will be followed-up in OPD for 3 months. After 3 months, females will be asked for their menstrual cycle duration and regularity. Reports will be assessed and levels will be recorded. If females will have regular cycles, then it will be noted. Females will be asked to give a blood sample on 3rd day of menstrual cycle and LH/FSH ratio will be noted. All this data will be recorded in a specially designed proforma.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Myoinositol', 'type': 'DRUG', 'description': 'In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months.', 'armGroupLabels': ['In group A, females will be prescribed oral myoinositol 1g twice daily for 3 months']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'In group B, females will be prescribed oral sustained-release metformin 850 mg twice daily for 3 months.', 'armGroupLabels': ['In group B, females will be prescribed oral metformin 850 mg twice daily for 3 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52230', 'city': 'Gujranwala', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Syeda Uzma, MBBS, FCPS', 'role': 'CONTACT', 'email': 'syedshezihussain78@gmail.com', 'phone': '+92348914083'}], 'facility': 'CMH Gujranwala', 'geoPoint': {'lat': 32.27377, 'lon': 72.93751}}], 'centralContacts': [{'name': 'Dr Fatima Tariq, MBBS', 'role': 'CONTACT', 'email': 'ftmtariq@yahoo.com', 'phone': '+92315491846'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Tariq', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatima Tariq', 'investigatorAffiliation': 'Combined Military Hospital Gujranwala'}}}}