Treatment of Adolescent Polycystic Ovary Syndrome (PCOS)
Overview[ - collapse ][ - ]
Purpose | A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood) |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Drug: Oral Contraceptive Pills (Yasmin) Behavioral: Lifestyle Modification Drug: placebo |
Phase | Phase 3 |
Sponsor | University of Rochester |
Responsible Party | University of Rochester |
ClinicalTrials.gov Identifier | NCT00714233 |
First Received | July 8, 2008 |
Last Updated | August 12, 2011 |
Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | July 8, 2008 |
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Last Updated Date | August 12, 2011 |
Start Date | August 2002 |
Estimated Primary Completion Date | December 2007 |
Current Primary Outcome Measures | Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification [Time Frame: 24 week] [Designated as safety issue: No]The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Treatment of Adolescent Polycystic Ovary Syndrome (PCOS) |
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Official Title | Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents |
Brief Summary | A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood) |
Detailed Description | Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern. Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished. |
Study Type | Interventional |
Study Phase | Phase 3 |
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 425mg. capsules, 2 capsules BID x 24 weeks Drug: Oral Contraceptive Pills (Yasmin) Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks Other Names: Yasmin oral COntraceptive tabsBehavioral: Lifestyle Modification weekly classes x 24 weeks for training in diet, exercise and behavior modification skills Drug: placebo placebo to the active metformin arm. 2 capsules BID x 24 weeks. Other Names: pharmacy matched placebo capsules |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 43 |
Estimated Completion Date | December 2007 |
Estimated Primary Completion Date | April 2004 |
Eligibility Criteria | Inclusion Criteria: - Menstrual irregularity defined as cycle length > 45 days - Overweight as BMI > 25 - Clinical evidence of hirsuitism or acne - Testosterone > 50ng/dL Exclusion Criteria: - History of diabetes mellitus - History of Cushing's disease - History of hyperprolactinemia - Untreated hypo or hyperthyroidism - History of adrenal hyperplasia - Significant renal impairment - Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study - Exercise > 10 hours per week |
Gender | Female |
Ages | 12 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00714233 |
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Other Study ID Numbers | RSRB # 09354 |
Has Data Monitoring Committee | No |
Information Provided By | University of Rochester |
Study Sponsor | University of Rochester |
Collaborators | Not Provided |
Investigators | Principal Investigator: Kathleen M Hoeger, MD University of Rochester |
Verification Date | May 2011 |