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Diet and Lifestyle Studies of PCOS

Polycystic Ovary Syndrome (PCOS) – Studies With Open Enrollment

Please Note:

Details of the following PCOS research studies into the effects of medication and/or diet and lifestyle interventions on polycystic ovary syndrome are offered for informational purposes only. For more details, use the contact details provided.

The following is a list of the current research studies for women with PCOS, under the direction of Dr. Richard Legro, at the Penn State Milton S. Hershey Medical Center in Hershey, PA. These research studies have been approved by the Institutional Review Board under FDA regulations at Penn State Milton S. Hershey Medical Center.

Study #1 Title: Genetics of PCOS (#97-041 & 94-088)

Study Brief: A national study involving questionnaires and blood work to locate the gene for PCOS. Eligible study participants must have 6 or fewer menses per year and a sibling or siblings and/or a parent willing to participate. Family members will also be asked to complete questionnaires and have blood work done at a local lab if they are eligible. Study participants cannot be taking any hormonal medications/ birth control pills to be in the study. This study involves a hormonal evaluation to diagnose PCOS through lab work at no charge, which can be done via a local laboratory or at Penn State Hershey Medical Center. All study participants will receive compensation upon completion of the study.

Contact: Barb Scheetz, Research Coordinator at 1-800-585-9585.

Study # 4 Title: A 4-month Double-Blind Randomized Trial of Atorvastatin for the Treatment of PCOS in Women with Elevated LDL-Cholesterol (#2001-179)

Study Brief: This research study is studying the use of the drug, atorvastatin, (Lipitor), to see if it will both lower blood cholesterol levels and improve the rate of ovulation in women with PCOS who have elevated LDL-cholesterol. The purpose of the study is to determine the safety and efficacy of atorvastatin for the treatment of PCOS. We are looking for women with PCOS ages 18-40 with a fasting LDL-Cholesterol level above 100 mg/dL and elevated male hormone levels. The study involves traveling the Hershey Medical Center six times over a 4-month period. You will be assigned by chance to receive either 40 mg of atorvastatin or a placebo pill (inactive pill). The study will involve checkups every 4 weeks. Oral glucose tolerance tests will be done prior to and at completion of the study. All women will be monitored for side effects and pregnancy while on the medication.

Contact: Jamie Ober at 1-800-585-9585 or 717-531-6272.

Study # 5 Title: Insulin Resistance Markers in Children (Study #2000-149)

Study Brief: We are starting a new research study to identify early warning signs of type 2 diabetes in children. We are seeking children, ages 5 to 14 years old, who have mothers with polycystic ovary syndrome, to enroll in this important study. The research study involves one 3-4 hour visit every year for 5 years. There will be a total of 6 visits. During each visit, the procedures include a sugar test and if the child is 8 years old or older, the study will also include drawing blood. The child will receive a U.S. Savings Bond for participation in the study. (Study #2000-149)

For more information, please contact Barb Scheetz at 1-800-585-9585 or 717-531-4483.

Study #8 Title: The Effect of Combination Therapy with Lifestyle Intervention and Metformin in Females with PCOS (Child)

The purpose of this study is to offer your child the opportunity to take part in a study because she has the condition known as Polycystic Ovary Syndrome (PCOS). PCOS is a condition that causes irregular periods, inability to get pregnant, and excessive facial and body hair. The United States Food and Drug Administration approve the drug used in this study, Metformin, for the treatment of Type II diabetes. However, it is commonly used in PCOS patients because of the inability to properly process insulin, a hormone that controls blood sugar. This study is designed to compare the drug Metformin, combined with exercise versus placebo (pill with no medication) combined with exercise in females with PCOS. The study will examine the effect of these two different combinations on the frequency of egg release from the ovaries, hyperandrogenemia (increased levels of male hormones), and your sensitivity to insulin.

The study involves traveling to the Hershey Medical Center every month after an initial visit over a 6-month period. Your child will be assigned to one of two treatment groups. One being Metformin combined with exercise, or placebo (pill with no medication) combined with exercise.

The procedures that will take place at every monthly visit include a pregnancy test, medical history, physical exam, blood pressure, height and weight measurements, review of medications, hirsutism and acne score,dietary and exercise counseling, and an exercise test. Blood work will be done to determine sex hormone levels and other hormones in the body at the initial visit, 12 month visit, and at the final visit. DXA scanning and a transvaginal/transabdominal ultrasound will be done at the baseline visit and at the final visit. Lastly, a bleeding diary will be collected every month for the 6-month period after your childs initial visit.

Contact Patricia Rawa at 1-800-585-9585 or 717-531-3692.

Study #9 Title: The Effect of Combination Therapy with Lifestyle Intervention and Metformin in Females with PCOS (Adult)

The purpose of this study is to offer you the opportunity to take part in a study because you have the condition known as Polycystic Ovary Syndrome (PCOS). PCOS is a condition that causes irregular periods, inability to get pregnant, and excessive facial and body hair. The United States Food and Drug Administration approve the drug used in this study, Metformin, for the treatment of Type II diabetes. However, it is commonly used in PCOS patients because of the inability to properly process insulin, a hormone that controls blood sugar. This study is designed to compare the drug Metformin, combined with exercise versus placebo (pill with no medication) combined with exercise in females with PCOS. The study will examine the effect of these two different combinations on the frequency of egg release from the ovaries, hyperandrogenemia (increased levels of male hormones), and your sensitivity to insulin.

The study involves traveling to the Hershey Medical Center every month after an initial visit over a 6-month period. You will be assigned to one of two treatment groups. One being Metformin combined with exercise, or placebo (pill with no medication) combined with exercise.

The procedures that will take place at every monthly visit include a pregnancy test, medical history, physical exam, blood pressure, height and weight measurements, review of medications, hirsutism and acne score,dietary and exercise counseling, and an exercise test. Blood work will be done to determine sex hormone levels and other hormones in the body at the initial visit, 12 month visit, and at the final visit. DXA scanning and a transvaginal ultrasound will be done at the baseline visit and at the final visit. Lastly, daily urine samples and a daily urine collection and bleeding diary will be collected every month for the 6-month period after your initial visit. We will supply you with all the materials for the urine collection.

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