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Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

NCT01103518 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-08-06

No results posted yet for this study

Summary

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.

Conditions

  • Amenorrhea
  • Dysmenorrhea
  • Menstruation Disturbances
  • Hyperandrogenism

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.

Sponsors & Collaborators

  • Fundação Educacional Serra dos Órgãos

    lead OTHER

Principal Investigators

  • Carlos RB Gama, M.D. · Fundação Educacional Serra dos Órgãos

  • Carlos P Nunes, M.D. · Fundação Educacional Serra dos Órgãos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-11-30
Completion
2011-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103518 on ClinicalTrials.gov