Overview

This trial is active, not recruiting.

Conditions amenorrhea, dysmenorrhea, menstruation disturbances, hyperandrogenism
Treatment ethinyl estradiol + cyproterone acetate
Phase phase 4
Sponsor Fundação Educacional Serra dos Órgãos
Start date December 2009
End date November 2010
Trial size 100 participants
Trial identifier NCT01103518, AMI 1-16-08-09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Ethinyl Estradiol + Cyproterone acetate
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.
(Active Comparator)
Ethinyl Estradiol + Cyproterone acetate
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.

Primary Outcomes

Measure
Regular Menstruation
time frame: Treatment month 3

Secondary Outcomes

Measure
Menstrual flow
time frame: Treatment months 3
Menstrual colic
time frame: Treatment month 3
Global self evaluation scores
time frame: Treatment month 6
Willingness to continue treatment
time frame: Treatment month 6
Safety
time frame: Treatment and follow-up period
Menstrual Flow
time frame: Treatment month 4
Menstrual Flow
time frame: Treatment month 5
Menstrual Colic
time frame: Treatment month 4
Menstrual Colic
time frame: Treatment month 5

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - Female subject - Premenopausal subject - 18 years or older - Medical history of irregular menses lasting at least 3 months - Signature of informed consent Exclusion Criteria: - Pregnancy - Use of hormonal contraceptives within 3 months of screening - Primary bilateral oophorectomy - Chemotherapy and / or radiotherapy within 6 months of screening - Hysterectomy - Myotonic dystrophy - Galactosemia - Galactorrhea - History of tuberculosis or schistosomiasis - Elevated prolactin / other significant laboratory alterations - Diabetes - Premature ovarian deficiency - Sensitivity to any component of the drug formula

Additional Information

Official title Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
Principal investigator Carlos RB Gama, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Fundação Educacional Serra dos Órgãos.