Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.

Study Overview
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Brief Summary
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The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). The objective of this study is to compare the effects of a long term administration of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile were performed at baseline and after 6 and 12 months of therapy.

Official Title
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Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study.

Conditions
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Polycystic Ovary Syndrome, Estro-progestin Drugs

Intervention / Treatment
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* Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol
* Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal weight women with Polycystic ovary syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003. Exclusion Criteria: pregnancy past history of cardiovascular disease, diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test), hypertension significant liver or renal impairment other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs) neoplasms unstable mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 mg drospirenone and 20 µg ethinyl-estradiol<br> | Drug: 3 mg drospirenone and 20 µg ethinyl-estradiol<br> <br> |
| Active Comparator: 3 mg drospirenone and 30 µg ethinyl-estradiol<br> | Drug: 3 mg drospirenone and 30 µg ethinyl-estradiol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women | hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp and lipid profile | twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, drospirenone ethinylestradiol, androgens, metabolism