Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-01-04 @ 4:46 PM
Study NCT ID:
NCT03134157
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine fibroid size', 'timeFrame': '3 months', 'description': 'Evaluation the size of Uterine fibroid withultrasound.'}], 'secondaryOutcomes': [{'measure': 'Uterine size', 'timeFrame': '3months', 'description': 'Evaluation the uterine size with ultrasound.'}, {'measure': 'Plasma concentration of Vitamin D3', 'timeFrame': '3 months', 'description': 'Evaluation the Plasma concentration of Vitamin D3 with blood sampling.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leiomyoma simvastatin infertility'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.', 'detailedDescription': "The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.\n\nCBC, Lipid profile, kidney \\& Liver function tests, FBS \\& hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20-40 years\n* Intramural Fibroids confirmed by ultrasound\n* Presence of at least one fibroid with size \\>4 cm or two fibroids with size \\>3 cm detected by pelvic ultrasound.\n* Presence of at least 3 fibroids with size \\<3 cm and a history of 2 IVF failures.\n* Number of fibroids ≤ 5\n* BMI\\>25 Kg/m2\n\nExclusion Criteria:\n\n* Pregnancy\n* Hormonal contraception or any hormonal therapy received in the last 3 months\n* Alcohol consumption\n* Allergic to simvastatin\n* Suspicion or diagnosis of cancer\n* Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract\n* Hb ≤ 7\n* Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month.\n* Severe male factor\n* Severe endometriosis\n* Diminished ovarian reserve'}, 'identificationModule': {'nctId': 'NCT03134157', 'briefTitle': 'The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients', 'orgStudyIdInfo': {'id': 'Royan-Emb-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin and vaginal placebo', 'description': 'The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months.', 'interventionNames': ['Drug: oral drug and vaginal placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Simvastatin and oral placebo', 'description': 'The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months.', 'interventionNames': ['Drug: oral drug and oral placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vaginal placebo+ oral placebo', 'description': 'The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months.', 'interventionNames': ['Drug: Vaginal placebo+ oral placebo']}], 'interventions': [{'name': 'oral drug and vaginal placebo', 'type': 'DRUG', 'description': 'prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.', 'armGroupLabels': ['Simvastatin and vaginal placebo']}, {'name': 'oral drug and oral placebo', 'type': 'DRUG', 'description': 'prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.', 'armGroupLabels': ['Simvastatin and oral placebo']}, {'name': 'Vaginal placebo+ oral placebo', 'type': 'DRUG', 'description': 'prescription of Vaginal placebo + oral placebo every day for 3 months.', 'armGroupLabels': ['Vaginal placebo+ oral placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehrān', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '(+98)2123562000', 'phoneExt': '516'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'email': 'Leara91@gmail.com', 'phone': '(+98)2123562000', 'phoneExt': '414'}, {'name': 'Firoozeh Ghafari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Elham Amirchaghmaghi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Farnaz Akbari, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amir Almasi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royan Institute', 'geoPoint': {'lat': 27.45845, 'lon': 55.47624}}], 'centralContacts': [{'name': 'Nasser Aghdami, MD,PhD', 'role': 'CONTACT', 'email': 'nasser.aghdami@royaninstitute.org', 'phone': '(+98)23562000', 'phoneExt': '516'}, {'name': 'Leila Arab, MD', 'role': 'CONTACT', 'phone': '(+98)23562000', 'phoneExt': '414'}], 'overallOfficials': [{'name': 'Mahnaz Ashrafi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': ') Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran'}, {'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Firoozeh Ahmadi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': ') Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran'}, {'name': 'Nadia Jahangiri, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': ') Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}