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MEDIA CENTER With This Ring . . . NEW YORK, NY (15 February 2007)—The Population Council has launched a study to test the safety and efficacy of its vaginal ring, a contraceptive that is designed to be used for one year. The vaginal ring currently available to American women must be discarded after three weeks of use, so at least 13 rings are needed annually. A product that is purchased only once a year may result in lower costs and fewer trips to the doctor and pharmacy. With less to manufacture and less to discard, a product that is replaced annually could also have a reduced impact on the environment.
The Council’s study is one of two investigations—collectively involving 2,200 women at 22 sites on four continents—being conducted in preparation for submitting the ring for consideration by the US Food and Drug Administration (FDA). Before the product can be put on the market, the FDA mandates that two large-scale studies, known collectively as a Phase 3 trial, be completed. The Council is working at ten sites here and abroad in collaboration with the World Health Organization, with funding from the US Agency for International Development. The National Institute of Child Health and Human Development, National Institutes of Health, is conducting vaginal ring trials at 12 additional sites across the United States via its Contraceptive Clinical Trials Network. Study participants are instructed to keep the contraceptive ring in place for three weeks and then remove it for one week to permit periodic bleeding. Seven days later the device is to be re-inserted. Preliminary research in women suggests that the one-year ring is as effective as oral contraceptives in preventing pregnancy. It was well-liked and well-accepted everywhere it was tested. The ring's side effects are expected to be similar to those of existing combined hormonal methods. "One of the most exciting features of the re-usable ring is that it is entirely under the woman's control," said Ruth Merkatz, R.N., Ph.D., the Population Council's director of clinical development. "This product could be attractive to women throughout the world, including those with limited access to health care services." Although a steady increase in contraceptive use has been observed worldwide, the family planning needs of many couples are unmet, and the number of unintended pregnancies continues to increase. The largest generation of young people in history is now making the transition from childhood to adulthood. This increase in the number of childbearing adults means that billions of new couples will need contraception in the next half century. Additional options will also be beneficial to American women—who, in order to achieve the typically desired family size of two children, must use family planning methods for about three decades. While some type of contraceptive use is nearly universal among women of reproductive age in this country, half of all pregnancies in the United States are unintended, and four in ten of these end in induced abortion. An additional 7 percent of American women aged 15–44 do not want to become pregnant, but are not using any contraception. "Clearly there is a gap between what women want in a family planning product and what is available," says Ruth Merkatz. "The one-year ring enhances the opportunities for women and families to achieve health, personal, and reproductive goals."
Making contraception easier to use may also reduce the failure rate associated with products that need attention every day. For example, more than 11 million American women take daily contraceptive pills, the most popular family planning method in the United States. In theory, consistent, correct use of the pill would result in virtually no one getting pregnant. In reality, 8 percent of this group will have an unintended pregnancy during the first year of product use. The difference between theoretical and actual efficacy of other family planning methods is even more pronounced. The Council’s vaginal ring is a thin, flexible product made of silicone rubber. It contains Nestorone®, a synthetic progestin similar to the natural hormone progesterone, and a low dose of ethinyl estradiol, a synthetic estrogen. The ring inhibits ovulation by continuously releasing a low dose of hormones through the vaginal walls and then the bloodstream. To better understand the safety of the product, researchers are including smokers and/or overweight women in the trials. These populations typically have been excluded in studies of hormonal contraception. This inclusive testing model is designed to provide a more comprehensive assessment of the risks and benefits of using the one-year ring. The Phase 3 trials will close in mid-2009. Using the safety and efficacy data collected and other information, the FDA will then decide whether the product can be approved for use in the United States. The procedure for submitting a New Drug Application and the FDA’s approval process may take an additional two years. Therefore, if testing indicates that the product is successful, and the administration okays the contraceptive, a one-year ring could be approved for use in about five years. During the study Population Council scientists will conduct interviews to further assess the method's acceptability among trial participants. An independent data safety monitoring board will review safety and efficacy information regularly throughout the trial, which is scheduled to last for approximately 30 months. About the Population Council ### Media contacts See Also Offsite Links
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