Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Phase 4

• Conditions: Amenorrhea; Dysmenorrhea; Menstruation Disturbances; Hyperandrogenism
• Interventions: Drug: Ethinyl Estradiol + Cyproterone acetate

• Registration Number: NCT01103518
• Lead Sponsor: Fundação Educacional Serra dos Órgãos

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06
• Primary Completion: 2010-11
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female subject
• Premenopausal subject
• 18 years or older
• Medical history of irregular menses lasting at least 3 months
• Signature of informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination 1	Ethinyl Estradiol + Cyproterone acetate	Ethinyl Estradiol + Cyproterone acetate
Combination 2	Ethinyl Estradiol + Cyproterone acetate	Ethinyl Estradiol + Cyproterone acetate

Primary Outcome Measures

Name	Time	Method
Regular Menstruation	Treatment month 3	Percentage of subjects with regular menstruation at the end of treatment month 3

Secondary Outcome Measures

Name	Time	Method
Menstrual flow	Treatment months 3	Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3
Menstrual colic	Treatment month 3	Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3.
Global self evaluation scores	Treatment month 6	Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition.
Willingness to continue treatment	Treatment month 6	Percentage of subjects willing to continue treatment with study drug
Safety	Treatment and follow-up period	Incidence, duration and severity of adverse events, including laboratory tests.
Menstrual Flow	Treatment month 5	Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5.
Menstrual Colic	Treatment month 5	Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5.

Trial Locations

Locations (1)

Hospital das Clínicas de Teresópolis; 🇧🇷 Teresópolis, Rio de Janeiro, Brazil