Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome
Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome
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
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 authors failed to observe those changes. However, an off label indication for it usage
 in PCOS for FDA and the lack of large controlled trials, MTF indication to treat PCOS has
 grown dramatically in later years.

 In obese women with PCOS, weight loss effectively ameliorates hyperandrogenism and metabolic
 disorders by improving insulin resistance.

 Some trials have suggested that those effects could be improved with insulin sensitizing
 agents without changes in body weigh.

 The present study was designed to assess, in a randomized, double-blind, placebo-controlled
 way, the effects of MTF in addition to lifestyle modifications on endocrine and metabolic
 disturbances in women with PCOS.
Inclusion Criteria:

 -  Women in reproductive age

 -  With polycystic ovary syndrome defined by hyperandrogenism (elevated serum
 testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or
 amenorrhea (no menses in the last 6 months) after negative screening pregnancy test

 Exclusion Criteria:

 -  Pregnancy

 -  Cushing' s syndrome

 -  Late onset congenital adrenal hyperplasia

 -  Androgen-secreting tumors

 -  Uncontrolled thyroid disease

 -  Hyperprolactinemia

 -  Diabetes any

 -  Cardiovascular diseases (Ischaemic heart disease, uncontrolled hypertension, heart
 failure)

 -  Acute or chronic infections at baseline

 -  Renal disease

 -  Liver disease

 -  Had taken any medications for at least 3 months before enrolment in the study.