Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Privado de Cordoba, Argentina
• Treatments: Metformin

Criteria

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.