18 Years
35 Years
Female
Polycystic Ovary Syndrome
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
causes).
Type of Study:
Interventional
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:
Yes
Authority:
Italy: National Institute of Health
Study ID:
disfunzionale14
NCT ID:
NCT01581814
Start Date:
October 2008
Completion Date:
March 2012
Related Keywords:
- Polycystic Ovary Syndrome
- PCOS
- Polycystic Ovary Syndrome
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