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Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome

Phase 4
20 Years
30 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome

Thirty young normal-weight anovulatory PCOS women will be enrolled. The diagnosis of PCOS
will be based on the presence of clinical [Ferriman-Gallwey score ≥ 8] or biochemical
hyperandrogenism (serum testosterone levels (>2 SD above our reference mean values) and
chronic anovulation [serum luteal progesterone (P) below 2 ng/mL)].

Patients will be randomly allocated into two groups (metformin and placebo group) using a
computer-software. Fifteen PCOS patients will be treated with metformin at a dosage of 1700
mg daily (one tablet of 850 mg twice daily; metformin group), whereas other 15 PCOS will be
treated with placebo tables (one tablet twice daily; placebo group). The duration of the
treatment will be 12 months. Patients will be instructed to follow their usual diet and
physical activity, and to use barrier contraception throughout the study. The length and the
frequency of the menstrual cycles, and the adverse experiences (AEs) will be reported on a
daily diary.

Each subject will undergo follow-up visits under (at six and 12 months from treatment
starting) and after treatment (at six and 12 months from treatment withdrawal). At each
follow-up visit, in all subjects the same operator will perform clinical, hormonal,
metabolic, and insulin sensitivity assessments by euglycemic hyperinsulinemic clamp.

Inclusion Criteria:

- Polycystic ovary syndrome (using NIH criteria).

Exclusion Criteria:

- Age <20 or >30 years;

- BMI higher than 25 and lower than 18;

- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent
medical illnesses;

- Hypothyroidism, hyperprolactinemia, Cushing’s syndrome, and non-classical congenital
adrenal hyperplasia;

- Current or previous use of oral contraceptives, glucocorticoids, antiandrogens,
ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal

- Intention to start a diet or a specific program of physical activity.

Type of Study:


Study Design:

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

Outcome Measure:

Insulin sensitivity by euglycemic hyperinsulinemic clamp

Principal Investigator

Stefano Palomba, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro


Italy: Italian Institute of Health

Study ID:




Start Date:

December 2003

Completion Date:

April 2006

Related Keywords:

  • Polycystic Ovary Syndrome
  • Insulin sensitivity
  • Insulin-sensitizing drug
  • Metformin
  • PCOS
  • Treatment
  • Polycystic Ovary Syndrome
  • Insulin Resistance