NCT01103518

Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fundação Educacional Serra dos Órgãos · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2010-04-14
• Last updated: 2010-08-06

Locations

1 site across 1 country: Brazil