Spin-offs of two established hormonal contraceptive methods will soon be the focus of clinical studies at Oregon Health & Science University's Women's Health Research Unit. These different takes on already popular contraceptives are expected to eliminate or reduce common hormonal side effects while appealing to women's lifestyles.
Menstrual cycle related symptoms and low hormonal doses characterize the first study, sponsored by the pharmaceutical company Warner Chilcott. This is the first study to look at the effects of extending the active pill cycle in an ultra-low dose estrogen contraceptive. Study participants will take 26 days of active pills, followed by two days of iron pills, as opposed to the typical oral contraceptive program, which consists of 21 days of active pills, followed by seven days of inactive placebo pills.
"Many women experience symptoms of pain, mood changes, headache or bloating during the pill free placebo week," said Jeffrey Jensen, M.D., M.P.H., director, Women's Health Research Unit, Center for Women's Health. "The goal of this study is to learn if these symptoms can be reduced by extending the cycle without causing abnormal bleeding patterns. The iron is an additional benefit!"
The second study, sponsored by the National Institute of Child Health and Human Development, seeks to establish the effectiveness of a long-lasting vaginal ring. The currently approved contraceptive vaginal ring NuvaRing is inserted into the vagina for three weeks, secreting hormones that prevent pregnancy, and removed from the vagina and thrown away at the start of the hormone-free no ring week. The woman must then obtain a brand new ring for her next cycle. In this model, "a women needs to go back to the drugstore to pick up more product every month. [Our] study vaginal ring can be used for an entire year," Jensen said.
The study ring, made of a flexible silicon rubber, releases a lower dose of hormones than most oral contraceptives. Jensen said he hopes that the combination of the convenience of the ring in addition to its lower hormone dose will increase the acceptability of vaginal contraception. He is the principle investigator of both of these studies and the Oregon Health & Science University Leon Speroff professor of obstetrics & gynecology.
"Contraception is a right all women are entitled to exercise. They should therefore be able to do so in a way that is the most comfortable to them," Heidi Printz, Ph.D., department manager, Women's Health Research Unit, said. "Research of this kind is crucial to this equation, because more choice increases the options available to women, and enables them to choose a method best suited to their needs and lifestyles."
The Women's Health Research Unit is currently recruiting women to participate in both of these studies. Each study is expected to begin this fall and continue for approximately one year. Participants will receive the study drug and well woman examinations connected with the study at no cost. Compensation is also available for complete participation on both of these studies. Interested women should call 503 494-3666 to determine their eligibility.
Consumers could expect to see these contraceptive products available from their contraceptive provider in two to three years, according to Jensen.
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The OHSU Center for Women's Health is a designated National Center of Excellence in Women's Health. The Women's Health Research Unit is a division of the Department of Obstetrics & Gynecology and an important part of the Center for Women's Health. Studies at the Women's Health Research Unit range from birth control options to treatment for the conditions associated with menopause. OBGYN board-certified physicians conduct all studies. Participants in these projects receive study drug, study-related lab tests and procedures at no cost and sometimes compensation for time and travel.