Clinical Trial: Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blin
Brief Summary:
Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also been related to cardiovascular disease.
The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin plus life style modifications in women with polycystic ovary syndrome compared with life style modifications and placebo
Detailed Summary:
Polycystic ovary syndrome (PCOS) is a common and heterogeneous disorder of women in reproductive age. It is characterized by hyperandrogenism and chronic anovulation. Several studies in diverse populations estimate it's prevalence at 5-10%. Women present, in a high percentage of cases, with obesity, hirsutism, acne, menstrual irregularities and infertility. Although the exact physiopathology of PCOS remains unknown, several studies tend to point to insulinoresistance (IR) as the cause of the syndrome. IR is present in 60 to 70% of patients independently of obesity. Compensatory hyperinsulinism has a pivotal role in the physiopathogenesis of PCOS. In vitro, insulin stimulates androgen synthesis in thecal cells and decrease sex hormone-binding globulin synthesis in the liver, increasing free androgen availability.
Due to the high prevalence of IR, PCOS shares components of metabolic syndrome: abdominal obesity, impaired glucose tolerance, gestational and type 2 diabetes, abnormalities in lipid profile, blood hypertension, endothelial dysfunction and probably cardiovascular disease.
In the past, PCOS treatment was focus on ovulation induction for infertility, oral contraceptives for irregular bleeding, and androgens antagonists for hirsutism or acne. In later years insulin sensitizing agents have been used to reduce hyperinsulinemia, improve ovary function and associated metabolic abnormalities. Metformin (MTF), a biguanide, usually used in obese patients with type 2 diabetes,inhibits glucose hepatic production,decreases insulin secretion and increases peripheral insulin sensitivity.
Some studies have reported an improvement in insulin sensitivity associated with reduction of hyperandrogenism and improvements in reproductive abnormalities with MTF. On the other hand, other aut
Sponsor: Hospital Privado de Cordoba, Argentina
Current Primary Outcome: Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hospital Privado de Cordoba, Argentina
Dates:
Date Received: May 15, 2008
Date Started: January 2003
Date Completion:
Last Updated: May 16, 2008
Last Verified: May 2008
