Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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 description: 
      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.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin 750 mg BID for 4 months; Diet counseling and exercise
Other intervention name(s): D.B.I. 500 mg. 1 1/2 tables BID
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Polycystic ovary syndrome; Treatment; Metformin