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Sponsored by: |
Hospital Privado de Cordoba, Argentina |
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Information provided by: | Hospital Privado de Cordoba, Argentina |
ClinicalTrials.gov Identifier: | NCT00679679 |
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
Condition | Intervention | Phase |
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Polycystic Ovary Syndrome |
Drug: Metformin Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
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- Blind and Placebo Control Trial |
Enrollment: | 30 |
Study Start Date: | January 2003 |
Study Completion Date: | December 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Metformin: Experimental
Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin
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Drug: Metformin
Metformin 750 mg BID for 4 months
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Placebo: Placebo Comparator
Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin
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Drug: Placebo
Diet counseling and exercise
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital Privado de Córdoba, Argentina ( Dr. Carolina Fux Otta ) |
Study ID Numbers: | Fux-1 |
Study First Received: | May 15, 2008 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00679679 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Polycystic ovary syndrome Treatment Metformin |
Genital Diseases, Female Gonadal Disorders Metformin Polycystic Ovary Syndrome Endocrine System Diseases |
Endocrinopathy Ovarian Diseases Cysts Ovarian Cysts |
Neoplasms Hypoglycemic Agents Pathologic Processes Disease |
Syndrome Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |