May 6, 2003 Given a choice, many women would probably opt out of the monthly cramping, bloating, bleeding and general discomfort that accompanies menstruation.
A study underway at Penn State Milton S. Hershey Medical Center is investigating whether a variation on the traditional oral contraceptive pill can prevent periods easily, safely and effectively.
Richard S. Legro, M.D., associate professor of obstetrics and gynecology, Penn State College of Medicine, was recently awarded a $562,500 grant from the U.S. Department of Health and Human Services, Public Health Service, to conduct a six-month study exploring the risks and benefits of continuous combined oral contraception, which may provide nearly full-proof protection against pregnancy while eliminating monthly menstrual bleeding and its symptoms.
“Menstrual bleeding may be medically unnecessary and can cause undesirable symptoms such as cramping, headaches and mood swings,” Legro said. “Not only is menstrual bleeding often an inconvenience, but it also can be a serious quality of life concern for many women. The idea of giving the pill a 28-day cycle with 21 active pills and a seven hormone-free pills was based primarily on the desire of the pill’s founder to mimic the natural menstrual cycle and reassure women and their doctors that the women weren’t pregnant.”
When used as indicated, current oral contraceptive pills prevent the release of an egg from a woman’s ovary. The hormones in the 21 active pills also cause a minimal amount of growth in the endometrium, the lining of the uterus. When the pills containing hormones run out after 21 days, the seven placebo, or non-medicated, pills cause the endometrium to break down and be shed during what’s often called, the “period.”
Continuous oral contraception uses pills that keep hormone levels consistent throughout the month, which may cause an even smaller amount of endometrial buildup in the uterus and prevent the monthly shedding altogether. In addition to reduced or absent menstrual bleeding, continuous suppression of the ovary may be more beneficial for treating gynecologic conditions related to menstrual function such as pelvic pain, endometriosis, and premenstrual syndrome. Some have suggested that the continuous pill regimen also may be more effective at preventing pregnancy because all pills have the same hormone level. So, missing a “key pill” (i.e. the first active pill of a new pack on the traditional regimen) will have no added penalty as it does with traditional oral contraception.
This is the first study to examine the effects of the continuous oral contraceptive pill on both ovarian and endometrial function for an extended period. Legro hopes this longer, six-month study, will show whether the body adjusts to continuous oral contraception, and whether breakthrough bleeding – bleeding that occurs at a time other than a woman’s period – which was a complaint in previous continuous oral contraception studies, ceases.
In the study, which has already begun enrolling patients, a total of 62 non-smoking women between the ages of 18 and 35 who also meet other conditions necessary for inclusion will be enrolled. Patients will undergo a number of screening tests and will be randomized into one of two study groups. One group will receive the continuous oral contraception with 28 active pills, and the other will receive the traditional 21 active pills and 7 placebo pills. The pill packets will be coded and neither patients nor investigators will know which patients are receiving which treatment. Subjects will be reimbursed for their participation in the study.
Study participants will visit the Penn State General Clinical Research Center at Penn State Hershey Medical Center each month to undergo tests and receive pill packets. An important aspect of the study is the participants’ reports of breakthrough bleeding.
One main goal of the study is to test whether there is a difference between the two groups in number of bleeding days. The study also will look at the actual physical changes in the women’s bodies including ovarian steroid production, the thickness of the endometrium, and other ovarian changes.
“Understanding the potential risks and benefits will allow physicians to give their patients the option of continuous oral contraception,” Legro said. “We hope this study will definitively show whether continuous oral contraception is preferable and beneficial to pill users.”
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