Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

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Transcrição

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
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.

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