Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundação Educacional Serra dos Órgãos
• Treatments: Cyproterone; Cyproterone Acetate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

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