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Phase 3
18 Years
35 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

CD4+CD28null frequency

Outcome Time Frame:

five minutes

Safety Issue:



Italy: National Institute of Health

Study ID:




Start Date:

October 2008

Completion Date:

March 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome