Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-28 @ 11:06 AM
Study NCT ID:
NCT01720459
Status:
UNKNOWN
Last Update Posted:
2012-11-02
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-01', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'testosterone serum concentration', 'timeFrame': '3 month therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome (PCOS)']}, 'referencesModule': {'references': [{'pmid': '27754722', 'type': 'DERIVED', 'citation': 'Banaszewska B, Wrotynska-Barczynska J, Spaczynski RZ, Pawelczyk L, Duleba AJ. Effects of Resveratrol on Polycystic Ovary Syndrome: A Double-blind, Randomized, Placebo-controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4322-4328. doi: 10.1210/jc.2016-1858. Epub 2016 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone \\>70ng/dl) and/or oligomenorrhea (\\<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound\n* Normal prolactin, TSH, 17-OH progesterone\n* No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly\n* Age 18-40\n\nExclusion Criteria:\n\n* Use of oral contraceptives and/or other steroid hormones 3 months prior to the study"}, 'identificationModule': {'nctId': 'NCT01720459', 'briefTitle': 'Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Effects of Micronized Trans-resveratrol Treatment on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Placebo-controlled Randomized Single-blind Study', 'orgStudyIdInfo': {'id': '681/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Micronized trans-resveratrol', 'description': 'Micronized trans-resveratrol', 'interventionNames': ['Dietary Supplement: Micronized trans-resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Micronized trans-resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)'], 'armGroupLabels': ['Micronized trans-resveratrol']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-535', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Beata Banaszewska, MD PhD', 'role': 'CONTACT', 'email': 'bbeata48@gmail.com', 'phone': '+48 61 8419412'}, {'name': 'Robert Z Spaczynski, MD PhD', 'role': 'CONTACT', 'email': 'rspaczynski@yahoo.com', 'phone': '+48 61 8419412'}], 'overallOfficials': [{'name': 'Leszek A Pawelczyk, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznan University of Medical Sciences'}, {'name': 'Antoni J Duleba, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Beata Banaszewska', 'investigatorAffiliation': 'Poznan University of Medical Sciences'}}}}