This study is not affiliated with PCOS Challenge, Inc.
The announcement below is being provided for informational purposes only.
COMET PCOS Research Study Seeking Women with Polycystic Ovary Syndrome in Pennsylvania*
Earn Up to $450 for Participation
See Below for Details and Eligibility Criteria
At University of PennsylvaniaWomen’s Health Clinical Research Center
|
At Penn State HealthMilton S. Hershey Medical Center
|
Study Title
The COMET-PCOS trial – Comparing the effects of Oral Contraceptive Pills (OCP) versus Metformin in the medical management of overweight/obese women with Polycystic Ovary Syndrome
Study Description
The Penn PCOS Center is conducting a clinical trial to compare the effects of medications on metabolic risk factors such as weight, blood pressure, glucose, and cholesterol levels in overweight/obese women with Polycystic Ovary Syndrome (PCOS) over a six-month period.
Metabolic Syndrome is the name for a group of risk factors that raises your risk for heart disease and other health problems, such as diabetes and stroke. OCP improve menstrual cycles and decrease male hormone levels. Metformin improves insulin sensitivity and some metabolic factors. Currently, there are no clear recommendations for the best and most comprehensive medical management of overweight/obese women with PCOS.
Goals
The study hopes to uncover whether OCP and Metformin together affect the prevalence of Metabolic syndrome, thereby altering the risk profile for the development of diabetesand cardiovascular disease in women with PCOS.
Eligible participants will be randomly assigned to one of three groups:
1) Birth Control Pills (to improve male hormone levels) + Placebo Pill
2) Metformin (to improve insulin levels) + Placebo Pill
3) Birth Control Pills + Metformin.
Your participation in this study will consist of a screening visit, followed by 5 study visits.
During this time, you will receive benefits including:
- Medications for 6 months
- Lifestyle and nutritional advice
- Physical exams
- Laboratory assessments
- Ultrasounds
- Bone density scans
- Compensation
Eligibility Criteria
Inclusion Criteria:
- Women ages 18-40
- Diagnosed with PCOS
- Overweight or obese
- Not seeking pregnancy
Exclusions
Exclusion Criteria:
- Currently pregnant or breast feeding
- History of Thyroid disease, Diabetes, Liver disease, Renal disease, Cushing Syndrome
- Women taking hormonal contraception or Metformin are allowed to participate after the medication is discontinued for 1 month.
- Bariatric surgery within the last 12 months.
Compensation
Earn up to $450 for participation
Locations
University of PennsylvaniaWomen’s Health Clinical Research Center |
Milton S. Hershey Medical CenterClinical Research Center |
Principal Investigators
University of PennsylvaniaAnuja Dokras, MD, PhD |
Penn State HealthRichard S. Legro, M.D. |
Where to Go For Further Information and
How to Apply
At University of PennsylvaniaCall (215) 662-7727 or  |
At Penn State HealthCall (717) 531-3692 or |
*Disclaimer
This study is not affiliated with PCOS Challenge, Inc. PCOS Challenge, Inc. does not recommend or endorse any specific studies, tests, physicians, products, procedures, opinions, or other information from third parties that may be mentioned on the PCOS Challenge websites. Any such mention is for information purposes only. Any third party services, products and websites, including those offered by affiliates, sponsors and advertisers, which may be accessed through the PCOS Challenge websites are the sole responsibility of the third party who is offering the service, product or posting the website. PCOS Challenge, Inc. makes no warranty as to the accuracy of any information on third party websites and accepts no liability for any claims, errors, and omissions or for any damage or injury to persons or property arising out of the use or operation of any services, products, materials, instructions, methods, ideas or procedures provided by third parties. Any offers, pricing, and/or promotions offered through the PCOS Challenge websites, affiliates, or any third party are subject change without notice at the sole discretion of the party making the offer. Read Full Disclaimer.
- Category: PCOS Research Studies
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