PCOS Study Guide
Welcome to AIA's PCOS Study Guide, a list of ongoing or upcoming research studies or clinical trials of interest to women with PCOS. It is through research studies like those listed below that new information about and treatments for PCOS will become available. If you are aware of any research studies or clinical trials that are not listed below, please contact us by e-mail at with any relevant information including a description of the study and a contact person.
Listings for additional studies may be found at the CenterWatch Clinical Trials Listing Service at http://www.centerwatch.com/studies/CAT313.HTM This site will be updated as new listings come in so please check back for new studies. Please read the disclaimer below first.
DISCLAIMER
AIA includes the following list of research studies and clinical trials and links for informational purposes only. The inclusion of announcements or links for research studies or clinical trials on the AIA website does not constitute an endorsement by AIA of any study or any particular medication or medical professional and the AIA expressly disclaims any and all liability or responsibility arising from an individual's decision to participate in any such study or clinical trial. The decision to participate in a research study or clinical trial is an individual one and should be made only after consultation with an individual's personal physician.
The Drug Approval Process
Many of you have wondered about the process by which medications become "FDA Approved." For example, some of the insulin sensitizing medications that you have seen discussed in articles on this website and elsewhere -- such as Glucophage, Rezulin, Avandia and Actos -- have not been "FDA approved" for non-diabetic women with PCOS, though they have been approved for people with diabetes. However, physicians are permitted to prescribe medications that are otherwise "FDA approved" for "off-label" indications with informed consent and close monitoring. Several of the studies listed below involve these medications. Another insulin sensitizing agent that you may have read about is d-chiro-inositol which is still under development but has yielded promising results in a research study published in The New England Journal of Medicine.
Before a prescription drug can be sold in the United States, it is tested until it meets U.S. Food and Drug Administration safety and efficacy standards as follows. First, preclinical testing uses laboratory tests and animal studies to synthesize a newly discovered drug and determine whether it is toxic. Second, in "phase one," 20 to 100 healthy volunteers use the drug to determine safe dosages and adverse reactions. Third, in "phase two," as many as several hundred people, all suffering from the same disorder, use the drug to determine its efficacy and to continue to monitor its safety. Fourth, in "phase three," more human testing is done to identify the most effective dose with the fewest potential side effects. Fifth, a new drug application allows the FDA to review all pertinent material about the drug so it can decide whether or not to approve it. Finally, "phase four" looks for side effects that may show up now that the drug is on the market and being taken by many more people than those in the initial clinical trials and studies.
New York City Area
Albert Einstein College of Medicine of Yeshiva University
Dr. Nanette Santoro and Dr. Harry Lieman of the Division of Reproductive Endocrinology of the Albert Einstein College of Medicine are conducting several research studies on polycystic ovarian syndrome, including a study looking into the genetics of PCOS, a study involving metformin and a study involving clomiphene citrate (clomid). For more information about these studies, contact Dr. Nanette Santoro, Director of the Division of Reproductive Endocrinology at .
Columbia-Presbyterian Medical Center
The Center for Menopause, Hormonal Disorders and Women's Health in the Department of Obstetrics and Gynecology at Columbia-Presbyterian Medical Center is conducting research studies on Polycystic Ovarian Syndrome. If you have irregular periods, infertility problems, acne and/or excess body hair, you may qualify for free medication, physical and gynecological examinations, lab work, sonograms and monetary travel reimbursement in upcoming research studies. For more information, please call .
Nationwide Studies
Brigham & Women's Hospital
See Massachusetts studies for description and contact information.
Massachsetts General Hospital
See Massachusetts studies for description and contact information.
Alabama
University of Alabama at Birmingham
See Virginia studies for description and contact information.
Massachusetts
Brigham & Women's Hospital
PCOS is an endocrine disorder that affects between 5 and 10% of women of reproductive age. It can cause irregular periods, excess hair growth, and decreased fertility. This research group found that PCOS is associated with insulin resistance; this finding led to the use of insulin-sensitizing drugs for treatment of PCOS. In addition, their studies have identified a candidate gene linked to PCOS. If you are between the ages of 18 and 45 and have been diagnosed with PCOS or think you might have it, you may be eligible for one of these two PCOS studies.
If you live near Boston, you may be eligible for the insulin action study. This study requires that you visit Brigham and Women's Hospital up to four times. You will be compensated up to $325.
If you do not live near Boston, you may be eligible for the nationwide PCOS study. This study requires that you and some of your family members give blood at a hospital near you. The study seeks to understand the inheritance of PCOS.
To participate in one of these studies, contact the following:
By e-mail at
By phone at
Or write to: PCOS Study/Andrea Dunaif, MD Laboratory
Brigham and Women's Hospital PBBA-A418
75 Francis Street
Boston, MA 02115
Provide a name and phone number and a member of the study staff will get back to you.
Massachusetts General Hospital
Nationwide Genetics Study
Dr. Ann Taylor of the Reproductive Endocrine Unit at Massachusetts General Hospital in Boston is conducting a PCOS Genetics research study. The purpose of this study is to investigate if PCOS is an inherited disorder. The study involves answering a PCOS medical history questionnaire and having your blood drawn for DNA testing. The DNA testing is anonymous and your blood will not be used for any other DNA testing except in the search for a PCOS gene. The testing will be done at NO cost to you.
After informed consent is obtained, you will be contacted to have your blood drawn at a lab or hospital local to you. There will be no cost to you for blood drawing and shipping to Massachusetts General Hospital.
Other PCOS Research Studies
In addition to the genetics study described above, Dr. Taylor and her colleagues have a number of other ongoing research studies - both in and out patient - for women with PCOS in the age ranges of 18 to 40 and 18 to 45. Inpatient admissions range from an overnight stay to a 3 night stay in the hospital. Admissions may be scheduled during weekdays as well as weekends. Most of the studies include IVGTTs (intravenous glucose tolerance tests) for evaluating insulin resistance. The stipends range from $125.00 to $500.00.
If you are interested in participating in this research or have any questions, please contact Dr. Ann Taylor or Cara J. Penney, PA-C at or
Missouri
Washington University, St. Louis, Missouri
See Virginia studies for description and contact information.
Pennsylvania
Pennsylvania State University, Hershey, Pennsylvania
Study # 1
Title: Genetics of PCOS
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 at least one biological sister and parents willing to participate, and be off birth control pills for at least 3 months. This study involves a free hormonal evaluation to diagnose PCOS via labwork, which can be done via a local laboratory.
Contact: Sharon Ward, Study Coordinator, or e-mail
Study # 2
Title: Sleep Apnea in PCOS Women
Study Brief: Must be able to spend the night in our sleep research lab at the Hershey Medical Center. Each participant must complete a questionnaire to determine eligibility and then will receive a free electrocardiogram, sleep assessment, and blood work and $100.00 reimbursement.
Contact: Sharon Ward, Study Coordinator, or e-mail
Study # 3
Title: The Effect of Diet in PCOS Women
Study Brief: Eligible study participants must be local to travel to the Hershey Medical Center. The study is four weeks long and all food for the diet will be provided to each study participant. Participants will be randomized to different diets and studied for effects. Baseline and weekly visits will be scheduled.
Contact: Sharon Ward, Study Coordinator, or e-mail
Study # 4
Title: The Effect of INS-1 on Insulin and Ovarian Androgen Production in Obese Women with PCOS
Study Brief: A thirteen week study. Eligible participants must be local to visit the Hershey Medical Center in Hershey, PA. Participants will be randomized to placebo or INS-1 (an insulin lowering agent). The goal of the study is to see if by improving the way your body uses insulin, you will have decreased symptoms of excess male hormones, decreased insulin levels and improved regularity of your menstrual cycle.
Contact: Betsy Shultz, , or e-mail
Study # 5
Title: The Effect of Metformin and a thiazolidinedione on PCOS
Study Brief: Eligible study participants must be able to travel to the Hershey Medical Center in Hershey, PA. The effects of these medications on ovulation frequency will be determined in a 3-6 month study with monthly visits.
Contact: Betsy Shultz, , or e-mail
Study # 6
Title: Insulin Resistance and Retinopathy
Study Brief: Eligible study participants must be able to travel to the Hershey Medical Center in Hershey, PA. The study will involve both hormonal and vision evaluations, followed by randomization to a medication for participants meeting criteria for further study.
Contact: Betsy Shultz, , or e-mail
Virginia
University of Virginia, Charlottesville, Virginia
Medical College of Virginia, Richmond, Virginia
If you have PCOS and were unable to get pregnant with clomid (clomiphene citrate), you may be qualified to participate in a medical research study. To qualify for the study, you must a) be 18-35 years, b) have failed to ovulate on 150 mg of clomid therapy (3 pills each day), c) have fewer than 6 menstrual periods annually and d) be in good health.
Compensation: Free study drug, clomid, labs and medical supervision provided.
This study is being conducted at the following sites:
1) Virginia Commonwealth University/Medical College of Virginia, Richmond, Virginia
Please contact Dr. Dale Stovall at /email:
or Dr. Manar Nazmy at /email:
2) University of Virginia, Charlottesville, Virginia
Please contact Laurie Hull, M.A. at /email:
3) Washington University, St. Louis, MO
Please contact Dr. Valerie Ratts at
4) University of Alabama at Birmingham
Please contact Dr. Ricardo Azziz at /email: or Vanessa Black at /email: