Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Fundação Educacional Serra dos Órgãos100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Amenorrhea Dysmenorrhea Menstruation Disturbances Hyperandrogenism

Interventions

Ethinyl Estradiol + Cyproterone acetateDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital das Clínicas de Teresópolis

Teresópolis, Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Regular Menstruation

Percentage of subjects with regular menstruation at the end of treatment month 3

Time frame: Treatment month 3

Secondary Outcomes

Menstrual flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3

Time frame: Treatment months 3

Menstrual colic

Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.

Time frame: Treatment month 3

Global self evaluation scores

Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.

Time frame: Treatment month 6

Willingness to continue treatment

Percentage of subjects willing to continue treatment with study drug

Time frame: Treatment month 6

Safety

Incidence, duration and severity of adverse events, including laboratory tests.

Time frame: Treatment and follow-up period

Menstrual Flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4

Time frame: Treatment month 4

Menstrual Flow

Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.

Time frame: Treatment month 5

Data from ClinicalTrials.gov

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