March 14, 1995
SF State women are being offered money and free birth control in exchange for testing one of three new methods of contraception that could be available as early as 1999.
If you are a woman at SF State you may have seen the florescent green or yellow posters in women's bathrooms and locker rooms that ask -- "Interested in a birth control research study?"
Conducted by UC San Francisco, the three studies which target women aged 18 to 35, include the still experimental vaginal ring which is inserted like a diaphragm, and releases hormones that get absorbed directly into the bloodstream. In another study, RU-486 is being tested for use as an emergency contraceptive, and the third study involves a new low dose birth control pill.
Women who consider participation in research studies should be clear about every aspect of the study before signing any forms, said Dr. Myra Lappin, director of SF State Student Health Service.
"I think the most important thing is to read the informed consent very carefully," Lappin said.
Low doses of norethindrone and estrogen are contained in the vaginal ring, according to Dr. Philip Darney, UCSF professor of obstetrics, gynecology and reproductive sciences. The vaginal ring is inserted into the vagina and pushed up against the cervix.
"The ring works by releasing slow and steady hormones through the mucosa in the vagina," Darney said. "The hormones are quickly absorbed... and enter directly into the bloodstream."
The ring, which is used for three months, is made of Silastic, the same material used in Norplant. It is shaped like a disc and is approximately four centimeters high and two-and-a-half inches in diameter.
The small vaginal ring is soft, making it less likely to be felt by women and their partners. Unlike a diaphragm, the ring is one size fits all.
It is removed once a month before menstruation. Once bleeding has stopped, it is re-inserted. Women who wish to remove the ring for a few hours can do so without fear of conception, according to Darney.
"It'll be the only woman-controlled, long-acting, sustained release birth control that doesn't require surgery," Darney said.
The vaginal ring also provides protection against pelvic inflammatory disease, according to Darney.
Studies on the vaginal ring began four years ago in Southern California. Since it is a relatively new method of contraception, no long term effects have been studied, Darney said. The current study in San Francisco began last month and will be conducted over the next six months. Participants will be paid $500.
"We expect it to be nearly as effective as birth control pills... 95 to 99 percent effective," Darney said.
The vaginal ring was developed by the Population Council, a nonprofit organization based in New York that was responsible for research done for the IUD (Intrauterine device) and Norplant."Cost will be the major drawback of the ring," Darney said. "If approved by the Food and Drug Administration for distribution, it would cost about $10 to $15 to manufacture. For the public, that could mean paying up to $50."
Since one ring lasts for three months, it will still be cheaper than a comparable supply of birth control pills.
Approval for the vaginal ring is at least four years away from general use according to Darney. So far only two women are enrolled in this study, although there are a few others on the waiting list, he said. UCSF hopes to enroll 20 women in this study.
Originally touted as the French abortion pill, the controversial drug RU-486 is now being studied by UCSF for use as emergency contraception to be taken within five days of unprotected intercourse to avoid a possible unwanted pregnancy.
In a press release, Dr. David Grimes, UCSF professor and vice chairman of obstetrics, gynecology science said that 150 Bay area women will be given the drug as a postcoital contraceptive or "morning-after" pill. The goal of the testing program is to determine the optimal dosage of the drug in preventing pregnancy, Grimes said.
Women who test positive for a pregnancy will not be given the drug. Only those who had unprotected intercourse mid-cycle and fear they will become pregnant can participate in the study, Darney said.
RU-486 blocks the action of progesterone, the hormone that initiates and maintains a pregnancy.
Testing for participation involves a routine physical exam. after which, two doses of RU-486 are taken at 12 hour intervals. Participants are asked to return for up to three more visits and will be monitored for any drug-related problems.
An earlier study conducted in Edinburgh, Scotland between August 1990 and December 1991 involving RU-486 as emergency contraception showed it had a higher success rate than the standard estrogen-progestogen regimen for emergency contraception currently used to prevent pregnancy. Side effects, including nausea, vomiting, breast tenderness and headaches were significantly lower among women who had taken RU-486.
According to the research, the only drawback found was that many of the women had menstrual periods that were up to two weeks late.
Another drawback may be price. Today abortions using RU-486 cost the same as surgical abortions.
The third study involving research on a low-dose birth control pill is aimed at women who, because of their medical history, are discouraged from taking birth control pills.
Current medical guidelines state that women with a history of heart disease, blood clotting disorders and smokers should not take birth control pills.
This study, by testing a significantly lower dose of hormones than those contained in standard birth pills, hopes to show that these women can safely use birth control as contraception regardless of their history, Darney said.
A commitment of up to three years is required to participate in this study. Women must return every three months for blood work and every six months for exams. According to Darney, researchers want to look at a range of clotting factors as well as thyroid and liver functions.
To be eligible to participate in any of the studies, you must be a disease-free, healthy, sexually active, monogamous woman. For research purposes, sexually active means that you have intercourse at least once a month.