Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02766803
Status:
UNKNOWN
Last Update Posted:
2016-09-08
First Post:
2016-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'testosterone serum concentration', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PCOS, Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '37462232', 'type': 'DERIVED', 'citation': 'Xiong T, Fraison E, Kolibianaki E, Costello MF, Venetis C, Kostova EB. Statins for women with polycystic ovary syndrome not actively trying to conceive. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD008565. doi: 10.1002/14651858.CD008565.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.\n\nThis study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.\n\nMethods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PCOs\n* insulin resistance\n* normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly\n\nExclusion Criteria:\n\n* use of oral contraceptives and/or other steroid hormones 3 months prior to the study"}, 'identificationModule': {'nctId': 'NCT02766803', 'briefTitle': 'Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.', 'orgStudyIdInfo': {'id': 'PoznanUMS 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin + resveratrol', 'description': 'simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily', 'interventionNames': ['Drug: Simvastatin and micronized trans-resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'simvastatin+ placebo', 'description': 'simvastatin 20 mg daily Placebo', 'interventionNames': ['Drug: Simvastatin and micronized trans-resveratrol']}], 'interventions': [{'name': 'Simvastatin and micronized trans-resveratrol', 'type': 'DRUG', 'armGroupLabels': ['Simvastatin + resveratrol', 'simvastatin+ placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-184', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Beata Banaszewska, Md Ph D', 'role': 'CONTACT', 'email': 'bbeata48@gmail.com', 'phone': '+48618419412'}, {'name': 'Robert Z Spaczynski, Md PhD Prof', 'role': 'CONTACT', 'email': 'rspaczynski@yahoo.com', 'phone': '+48618419412'}, {'name': 'Leszek A Pawelczyk, MD PhD Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Antoni J Duleba, MD Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD Ass Professor', 'investigatorFullName': 'Beata Banaszewska', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}