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

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Yasmin; Drug: Metformin plus Yasmin; Drug: Metformin

• Registration Number: NCT01581814
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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

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

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-07
• Study Completion: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-19
• Last Update Submitted: 2012-04-19
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.03 mg EE plus 3 mg of DRPS	Yasmin;	-
Metformin plus Yasmin	Metformin plus Yasmin	-
Metformin	Metformin	31 subjects were randomized to receive 500 mg Metformin per 3/die

Primary Outcome Measures

Name	Time	Method
CD4+CD28null frequency	five minutes

Secondary Outcome Measures

Name	Time	Method
the area under the curve for insulin (AUCi) and lipid profile.	120 minutes

Trial Locations

Locations (1)

Policlinico A. Gemelli; 🇮🇹 Rome, Italy