Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

NCT ID: NCT00679679

Last Updated: 2008-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-12-31

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 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; Treatment; Metformin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Metformin

Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 750 mg BID for 4 months

Placebo

Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Diet counseling and exercise

Interventions

Metformin

Metformin 750 mg BID for 4 months

Intervention Type: DRUG

Placebo

Diet counseling and exercise

Intervention Type: DRUG

Other Intervention Names

D.B.I. 500 mg. 1 1/2 tables BID

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Privado de Cordoba, Argentina

OTHER

Sponsor Role: lead

Responsible Party

Hospital Privado de Córdoba, Argentina

Principal Investigators

Carolina Fux Otta, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Privado de Córdoba

Córdoba, Córdoba Province, Argentina

Countries

Argentina

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Other Identifiers

Fux-1

Identifier Type: -

Identifier Source: org_study_id