Researchers at the National Institute of Child Health and Human Development (NICHD) are recruiting women with polycystic ovarian syndrome for a new treatment for the infertility associated with that condition. The NICHD study is seeking women who have not responded to the conventional therapy for the condition, treatment with the fertility drug clomiphene citrate.
Polycystic ovarian syndrome (PCOS) is a condition in which women may have acne, increased facial and body hair growth, irregular menstrual cycles, and difficulty in getting pregnant. From 5 to 10 percent of American women have the condition. About 50 percent of women with PCOS are obese; many also are at increased risk of having recurrent miscarriage, heart disease and diabetes. Because the syndrome was originally described by Drs. Stein and Leventhal, PCOS was once known as Stein-Leventhal Syndrome.
The NICHD study is recruiting women between the ages of 18 and 39 who have PCOS and who are interested in getting pregnant. Because women with PCOS have high levels of androgens (male hormones) circulating in their blood, NICHD scientists hypothesize that treating them with flutamide, a drug that blocks androgens, may allow them to ovulate.
Before being accepted in the study, volunteers will receive a comprehensive gynecologic and endocrinologic evaluation from physicians and the NIH clinical center. Women who are accepted for the study and consent to participate will be randomly assigned to one of two groups, either treatment with a placebo, or treatment with flutamide. After six weeks, both groups will be treated with clomiphene citrate, and observed to see if ovulation occurs. When the study is completed, women in the placebo part of the study will be given the option of receiving the flutamide treatment if it appears to be effective.
Women interested in participating in the study may call either the toll-free hotline at 1-888-644-8891, or 301-496-4686; E-mail inquiries may be directed to firstname.lastname@example.org.