Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
| Purpose | 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 |
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| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 4 |
| Sponsor | Hospital Privado de Cordoba, Argentina |
| Responsible Party | Hospital Privado de Cordoba, Argentina |
| ClinicalTrials.gov Identifier | NCT00679679 |
| First Received | May 15, 2008 |
| Last Updated | May 16, 2008 |
| Last verified | May 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 15, 2008 |
|---|---|
| Last Updated Date | May 16, 2008 |
| Start Date | January 2003 |
| Estimated Primary Completion Date | December 2005 |
| Current Primary Outcome Measures | Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific antigen [Time Frame: 4 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome |
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| 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 |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Metformin 750 mg BID for 4 months Other Names: D.B.I. 500 mg. 1 1/2 tables BIDDrug: Placebo Diet counseling and exercise |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 30 |
| Estimated Completion Date | December 2005 |
| Estimated Primary Completion Date | September 2005 |
| 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. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Argentina |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00679679 |
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| Other Study ID Numbers | Fux-1 |
| Has Data Monitoring Committee | No |
| Information Provided By | Hospital Privado de Cordoba, Argentina |
| Study Sponsor | Hospital Privado de Cordoba, Argentina |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Carolina Fux Otta, MD |
| Verification Date | May 2008 |
Locations[ + expand ][ + ]
| Hospital Privado de Córdoba | Cordoba, Argentina, X5016KEH |
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