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

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.

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