Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation
Status: Active, not recruiting
Study Phase: Phase 4
Start Date: December 2009 | Completion Date: January 2011
Condition(s): Amenorrhea, Dysmenorrhea, Menstruation Disturbances,
Hyperandrogenism
Full Title of Study
Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone
Acetate in Irregular Menstruation of Hyper-androgenic Origin
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Fundação Educacional Serra dos Órgãos
Principal Investigator: Carlos RB Gama, M.D. Fundação Educacional Serra dos Órgãos
Study Director: Carlos P Nunes, M.D. Fundação Educacional Serra dos Órgãos
Trial Location Details
Facility: Hospital das Clínicas de Teresópolis Teresópolis, Brazil
Interventions
Drug: Ethinyl Estradiol + Cyproterone acetate
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.
Information Source
ID Number: AMI 1-16-08-09
NCT Identifier: NCT01103518
Health Authority: Brazil: National Health Surveillance Agency
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT01103518
ClinicalTrials.gov processed this data on September 29, 2016
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