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OpenTrials
Completed

NCT Number: NCT01581814

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

metformin

Drug

500 mg of Metformin per 3/die

Yasmin;

Drug

1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)

Metformin plus Yasmin

Drug

0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily

Primary outcomes

  1. CD4+CD28null frequency

    Time frame: five minutes

Secondary outcomes

  1. the area under the curve for insulin (AUCi) and lipid profile.

    Time frame: 120 minutes

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 20, 2012
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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