Metformin Suspension and Insulin Sensitivity
Information source: University Magna Gaecia
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome
Intervention: Metformin cloridrate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Magna Gaecia Official(s) and/or principal investigator(s):
Stefano Palomba, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Summary
Metformin is an insulin sensitizing drug routinely used for the treatment of anovulatory
patients with polycystic ovary syndrome (PCOS). To date, the metabolic effects of the
long-term metformin administration are know but no data are available on the effects after
its suspension.
The purpose of this study is to evaluate the effects of metformin suspension on insulin
sensitivity in PCOS patients.
Clinical Details
Official title: Insulin Sensitivity After Metformin Suspension in Normal-Weight Women With Polycystic Ovary Syndrome
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Insulin sensitivity by euglycemic hyperinsulinemic clamp
Secondary outcome: Clinical, hormonal, and metabolic assessments
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 30 Years.
Gender(s): Female.
Criteria:
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
drugs;
- Intention to start a diet or a specific program of physical activity.
Locations and Contacts
"Pugliese" Hospital, Catanzaro 88100, Italy
"Pugliese" Hospital, Catanzaro 88100, Italy
Additional Information
Starting date: December 2003
Ending date: April 2006
Last updated: February 20, 2007
|
