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PENN STATE HERSHEY PHYSICIAN LEADS NATIONAL STUDY ON POLYCYSTIC OVARY SYNDROME
AND PREGNANCY
The PPCOS study is a double-blind, randomized trial comparing metformin XR,
clomiphene citrate, and a combination of metformin XR and clomiphene citrate
in women with polycystic ovary syndrome. The study hopes to answer the question
of which treatment type will be most likely to achieve pregnancy the quickest.
There will be 13 centers across the United States participating in this study.
Patient recruitment started in the fall of 2002 and will continue until a total
of 678 patients have been enrolled. Each patient will be randomized to receive
one of the three treatments. No one, not even the doctors, will know which medication
the patient is receiving. The study medications will continue until a pregnancy
results, there have been 6 cycles with ovulation, or 30 weeks.
To qualify to participate in this trial, patients must: Desire pregnancy
Women with PCOS who meet the inclusion criteria for the study will be randomized into one of three medication groups comparing: 1) metformin XR (a sustained-release version of metformin) and placebo – an inactive pill, 2) clomiphene citrate and placebo, and 3) metformin XR and clomiphene citrate. Each arm thus will contain at least one active medication that improves the chance for ovulation and, ultimately, pregnancy. This study aims to answer the question: Which is best?“This is a three-arm study because the principal hypothesis is that, like in the treatment of other complex disorders such as cancer or diabetes, a multi-agent, or combination treatment, is usually better than a single-agent one,” Legro said. The study is double-blind, meaning that neither the patient nor the physician will know which of the medication combinations is administered. Clomiphene citrate is the standard medication for infertility in women with PCOS. Metformin XR is FDA-approved to treat patients with Type II, or adult-onset, diabetes. It improves the way the body uses insulin, and thereby lowers glucose and insulin levels in the blood. Women with PCOS may have problems with excess insulin that may be contribute to the infertility and overproduction of male hormones,” Legro said. “Metformin XR has been used in women with PCOS to help them start ovulating; however, it has not been approved by the FDA for this use. This will be the largest study yet that examines its effects, alone and in combination.”Those who meet the qualifications for the study and choose to participate will receive the following free of charge: all study medications, cost of blood tests performed after enrollment in the study, a physical exam including an ultrasound of the ovaries, a pregnancy test and, if they become pregnant, an ultrasound to confirm it. The study has been approved by the Institutional Review Board under FDA regulations at Penn State College of Medicine. It is being conducted by the Reproductive Medicine Network, a group of eight academic medical centers who have received National Institutes of Health funding to study reproductive medicine issues. The RMN is sponsored and overseen at the NIH by the National Institute of Child Health and Human Development. This research is supported by NIH grant 5 U10 HD38992. In addition to Penn State College of Medicine at Penn State Milton S. Hershey Medical Center, the other RMN hospitals participating are: Baylor College of Medicine in Houston, Hospital at the University of Pennsylvania, University of Alabama at Birmingham, University of Colorado, University of Medicine and Dentistry of New Jersey at Newark, University of Texas Southwestern Medical Center, and Wayne State University in Detroit. The following participating hospitals are part of the Specialized Cooperative Centers Program in Reproductions Research funded by the NIH: University of North Carolina at Chapel Hill, Virginia Commonwealth University, Stanford University, University California of San Diego, and University of Pittsburgh. The landmark participation of these two programs was arranged by program officials at NICHD. To learn more about the studies being conducted at these institutuions please visit: http://rmn.dcri.duke.edu/ For more information or to be evaluated for the trial that Dr. Legro's team is conducting in Hershey, Pa., please call: Jamie Ober, RN |
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