Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients

Detailed Description
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Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Metformin
* Drug: Yasmin;
* Drug: Metformin plus Yasmin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-35 hyperinsulinemic PCOS Exclusion Criteria: chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>31 subjects were randomized to receive 500 mg Metformin per 3/die | Drug: Metformin<br>* 500 mg of Metformin per 3/die<br>|
| Active Comparator: 0.03 mg EE plus 3 mg of DRPS<br> | Drug: Yasmin;<br>* 1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)<br>|
| Active Comparator: Metformin plus Yasmin<br> | Drug: Metformin plus Yasmin<br>* 0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+CD28null frequency |  | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the area under the curve for insulin (AUCi) and lipid profile. |  | 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS