Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation

Study Overview
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Brief Summary
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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.

Official Title
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Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin

Conditions
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Amenorrhea, Dysmenorrhea, Menstruation Disturbances, Hyperandrogenism

Intervention / Treatment
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* Drug: Ethinyl Estradiol + Cyproterone acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination 1<br>Ethinyl Estradiol + Cyproterone acetate | Drug: Ethinyl Estradiol + Cyproterone acetate<br>* 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.<br>|
| Active Comparator: Combination 2<br>Ethinyl Estradiol + Cyproterone acetate | Drug: Ethinyl Estradiol + Cyproterone acetate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regular Menstruation | Percentage of subjects with regular menstruation at the end of treatment month 3 | Treatment month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Menstrual flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 3 | Treatment months 3 | 
| Menstrual colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 3. | Treatment month 3 | 
| Global self evaluation scores | Percentage of subjects with scores of 9 and 10 on the self evaluation of global condition. | Treatment month 6 | 
| Willingness to continue treatment | Percentage of subjects willing to continue treatment with study drug | Treatment month 6 | 
| Safety | Incidence, duration and severity of adverse events, including laboratory tests. | Treatment and follow-up period | 
| Menstrual Flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 4 | Treatment month 4 | 
| Menstrual Flow | Percentage of subjects with light, moderate, or heavy menstrual flow at treatment month 5. | Treatment month 5 | 
| Menstrual Colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 4. | Treatment month 4 | 
| Menstrual Colic | Percentage of subjects reporting menstrual colic at pretreatment and at treatment month 5. | Treatment month 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrual irregularity, Menstruation disturbances, Hyperandrogenism