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Phase 1
18 Years
35 Years
Open (Enrolling)
Polycystic Ovary Syndrome

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Trial Information

PCOS is the most common female endocrinopathy in reproductive age. This syndrome is a
heterogeneous condition characterized by several symptoms and clinical signs related to
reproductive, cardiometabolic and psychological disorders.We recently demonstrated that
young PCOS women show an expansion of an unusual T-cell population with proinflammatory
functions, identified by CD4+CD28null T lymphocytes . Of note, this T subpopulation has been
found to be expanded in patients with unstable angina, type 2 diabetes (DM2), in absence of
clinical evidence of CVD 12, and has been recently associated to recurrent coronary
instability .Based on the above mentioned evidences, the aim of the present study is 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 patientsTo evaluate long-term effects of drospirenone
(DRSP)/ethinylestradiol (EE) and NOMAC-valerate estardiol on some cardiovascular risk
factors in PCOS patients.

Inclusion Criteria:

- patients with PCOS aged 18-35 years

Exclusion Criteria:

- chronic or acute inflammatory disease

- cancer

- autoimmune disease

- treatment with clomiphene citrate

- 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:


Study Design:

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

Outcome Measure:

cardiovascular risk

Outcome Description:

total testosterone (T), SHBG, androstenedione (A), 17-hydroxyprogesterone (17-OHP), dehydroepiandrosterone sulphate (DHEAS), triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol (HDL and LDL cholesterol) and alanine aminotransferase (ALT),CD4+CD28null frequency

Outcome Time Frame:

120 minutes

Safety Issue:



Italy: National Institute of Health

Study ID:




Start Date:

April 2012

Completion Date:

October 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome