Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-21 @ 11:55 PM
Study NCT ID:
NCT01103518
Status:
UNKNOWN
Last Update Posted:
2010-08-06
First Post:
2010-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000568', 'term': 'Amenorrhea'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D017588', 'term': 'Hyperandrogenism'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D058489', 'term': '46, XX Disorders of Sex Development'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D047808', 'term': 'Adrenogenital Syndrome'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C032640', 'term': 'Cyproterone acetate, ethinyl estradiol drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regular Menstruation', 'timeFrame': 'Treatment month 3', 'description': 'Percentage of subjects with regular menstruation at the end of treatment month 3'}], 'secondaryOutcomes': [{'measure': 'Menstrual flow', 'timeFrame': 'Treatment months 3', 'description': 'Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3'}, {'measure': 'Menstrual colic', 'timeFrame': 'Treatment month 3', 'description': 'Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.'}, {'measure': 'Global self evaluation scores', 'timeFrame': 'Treatment month 6', 'description': 'Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.'}, {'measure': 'Willingness to continue treatment', 'timeFrame': 'Treatment month 6', 'description': 'Percentage of subjects willing to continue treatment with study drug'}, {'measure': 'Safety', 'timeFrame': 'Treatment and follow-up period', 'description': 'Incidence, duration and severity of adverse events, including laboratory tests.'}, {'measure': 'Menstrual Flow', 'timeFrame': 'Treatment month 4', 'description': 'Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4'}, {'measure': 'Menstrual Flow', 'timeFrame': 'Treatment month 5', 'description': 'Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.'}, {'measure': 'Menstrual Colic', 'timeFrame': 'Treatment month 4', 'description': 'Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4.'}, {'measure': 'Menstrual Colic', 'timeFrame': 'Treatment month 5', 'description': 'Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Menstrual irregularity', 'Menstruation disturbances', 'Hyperandrogenism'], 'conditions': ['Amenorrhea', 'Dysmenorrhea', 'Menstruation Disturbances', 'Hyperandrogenism']}, 'descriptionModule': {'briefSummary': 'This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subject\n* Premenopausal subject\n* 18 years or older\n* Medical history of irregular menses lasting at least 3 months\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of hormonal contraceptives within 3 months of screening\n* Primary bilateral oophorectomy\n* Chemotherapy and / or radiotherapy within 6 months of screening\n* Hysterectomy\n* Myotonic dystrophy\n* Galactosemia\n* Galactorrhea\n* History of tuberculosis or schistosomiasis\n* Elevated prolactin / other significant laboratory alterations\n* Diabetes\n* Premature ovarian deficiency\n* Sensitivity to any component of the drug formula'}, 'identificationModule': {'nctId': 'NCT01103518', 'briefTitle': 'Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation', 'organization': {'class': 'OTHER', 'fullName': 'Fundação Educacional Serra dos Órgãos'}, 'officialTitle': 'Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin', 'orgStudyIdInfo': {'id': 'AMI 1-16-08-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination 1', 'description': 'Ethinyl Estradiol + Cyproterone acetate', 'interventionNames': ['Drug: Ethinyl Estradiol + Cyproterone acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination 2', 'description': 'Ethinyl Estradiol + Cyproterone acetate', 'interventionNames': ['Drug: Ethinyl Estradiol + Cyproterone acetate']}], 'interventions': [{'name': 'Ethinyl Estradiol + Cyproterone acetate', 'type': 'DRUG', 'description': 'Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.', 'armGroupLabels': ['Combination 1', 'Combination 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25976-016', 'city': 'Teresópolis', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Teresópolis', 'geoPoint': {'lat': -22.4167, 'lon': -42.97822}}], 'overallOfficials': [{'name': 'Carlos RB Gama, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundação Educacional Serra dos Órgãos'}, {'name': 'Carlos P Nunes, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundação Educacional Serra dos Órgãos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundação Educacional Serra dos Órgãos', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Carlos Romualdo Barboza Gama', 'oldOrganization': 'Fundação Educacional Serra dos Órgãos'}}}}