Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Fundação Educacional Serra dos Órgãos

Status and phase: Unknown; Phase 4

Conditions: Menstruation Disturbances; Hyperandrogenism; Amenorrhea; Dysmenorrhea

Treatments: Drug: Ethinyl Estradiol + Cyproterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01103518

AMI 1-16-08-09

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Combination 1

Experimental group

Description:

Ethinyl Estradiol + Cyproterone acetate

Treatment:

Drug: Ethinyl Estradiol + Cyproterone acetate

Combination 2

Active Comparator group

Description:

Ethinyl Estradiol + Cyproterone acetate

Treatment:

Drug: Ethinyl Estradiol + Cyproterone acetate