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Sponsored by: |
Odense University Hospital |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00451568 |
Background: PCOS is a common condition with a prevalence of 5-8 % in premenopausal women. More than 50% of PCOS patients are insulin resistant and have a diabetes risk 5-8 times higher than age- and weight-matched controls. Studies using insulin sensitizers in PCOS found increased insulin sensitivity and decreased insulin levels to be followed by decreased androgen levels and improved ovulatory function. No studies however, evaluated the long term effects of insulin sensitizing treatment. Oral contraceptives normalize menstrual cycles and suppress androgen levels in PCOS, however no long-term studies evaluated the effects of combined treatment with metformin and oral contraceptives in PCOS. Design: Randomized open study in 3*30 PCOS patients. Patients are randomised to 24 months of treatment with 1: metformin, 2: metformin and oral contraceptives or 3: oral contraceptives. Primary outcome measures: fasting insulin, AUC insulin. Secundary endpoints: BMI, WHR, LH, FSH, total and free-testosterone, c-peptid, urinary cortisol, AUC for insulin, glucose and c-peptid during OGTT.
Inclusioncriteria:
Design:
Condition | Intervention | Phase |
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Polycystic Ovary Syndrome |
Drug: Metformin Drug: Yasmin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 90 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | April 2010 |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dorte Glintborg, MD, PhD | +45 6541 1769 | dorte.glintborg@dadlnet.dk |
Contact: Marianne Andersen, MD, PhD | +45 6541 1769 | marianne.andersen@ouh.regionsyddanmark.dk |
Denmark | |
Odense University Hospital | Recruiting |
Odense, Denmark | |
Contact: Dorte Glintborg, MD, PhD +45 6541 1769 dorte.glintborg@dadlnet.dk | |
Contact: Marianne Andersen, MD, PhD +45 6541 1769 marianne.andersen@ouh.regionsyddanmark.dk |
Principal Investigator: | Marianne Andersen, MD, PhD | Odense University Hospital |
Study ID Numbers: | 027 |
Study First Received: | March 22, 2007 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00451568 History of Changes |
Health Authority: | Denmark: National Board of Health |
Polycystic ovary syndrome |
Gonadal Disorders Contraceptive Agents Contraceptives, Oral Metformin Contraceptive Agents, Female Endocrine System Diseases Ovarian Diseases |
Cysts Polycystic Ovarian Syndrome Genital Diseases, Female Hypoglycemic Agents Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts |
Disease Contraceptive Agents Gonadal Disorders Physiological Effects of Drugs Metformin Contraceptives, Oral Contraceptive Agents, Female Endocrine System Diseases Reproductive Control Agents Ovarian Diseases Cysts |
Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Hypoglycemic Agents Pathologic Processes Therapeutic Uses Syndrome Polycystic Ovary Syndrome Ovarian Cysts |