L.A. Among Test Sites for Electronic Birth Control Device
Contraception could move into the Space Age with the initiation in nine U.S. cities--including Los Angeles and San Francisco--of a yearlong trial to study the reliability of an over-the-counter electronic birth control method.
New York-based Unipath Diagnostics Co. has recruited about half of the 300 couples it needs in Los Angeles to study the electronic monitor that measures two hormones in a woman’s urine to determine when she’s fertile and should abstain from sex.
The eyeglass case-sized device, known as the Persona in Europe, was developed by Unipath Diagnostics’ British-based sister company, Unipath Ltd. (Both are owned by the London-based home and personal products marketing giant Unilever.) Persona is currently available in the United Kingdom, Ireland and Italy.
Fifteen years in the making, the monitor uses hormonal measurement techniques used in Unipath’s pregnancy and fertility kits that are marketed under the Clearblue Easy and Clearplan Easy names.
The monitor is the only natural family-planning method undergoing study in the U.S. today, joining a raft of new hormonal and barrier contraceptives expected to be available here by 2005.
“Through the trials in Europe, we realized there was a large need for a new choice in contraception,” said Janet Jacobs, director of clinical research for Unipath Diagnostics. “There was a high level of dissatisfaction with other methods.”
About 25% of European women polled by Unipath said they were dissatisfied with their contraceptive choices, Jacobs said. A similar number of U.S. women are dissatisfied with the 15 birth control options available to them. Experts say an increasing number of U.S. women are tired of hormonal methods--a significant trend since the most popular contraceptive here is the Pill.
Unipath representatives say the California Family Health Council, the group conducting its Los Angeles trials, has received an enthusiastic response to a series of radio ads promoting the investigation.
“We hear over and over again the non-hormonal feature and newness are the two main points of attraction,” said Terri Walsh, research manager for the Los Angeles trial. “We’re having a difficult time getting everyone in.”
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To use the device, a woman must open it each day and check which of a series of three lights is shining. If the green light comes on, she is free to make love. If the red light appears, she should abstain from sex or use a contraceptive, and if the yellow light shines she must test her urine.
The urine test is done on a test strip attached to a plastic rod and inserted into the monitor. In the first month of use, the monitor will ask for 16 tests; in subsequent months it will request eight tests.
The monitor requests more tests in the beginning so it can begin to compile a picture of the woman’s individual cycle in its memory. It also relies on the woman to tell its microchip when her cycle begins each month by pushing a button on the monitor marked “M.”
The device reads the levels of estradiol--the hormone responsible for making a woman’s vagina more receptive to sperm--and luteinizing hormone, which causes an egg to rupture from the ovary.
When the levels of these hormones rise in the woman’s urine, the monitor will display a red light.
A woman can expect to receive 12 to 15 red days in the first few months as the monitor is working to learn her cycle. As the device learns more about her cycles, she will see from six to 10 red days a month, said Jacobs, who is overseeing the U.S. trial.
Medications known to affect the monitor’s function and accuracy are products that contain hormones and pure forms of tetracycline used to treat acne, Jacobs said.
The monitor was 94% effective in preventing pregnancy in European studies, she said. This rate is higher than barrier methods such as condoms or the diaphragm, which are about 82% effective, but lower than sterilization, and the relatively new hormone-based methods Norplant and Depo Provera, which are rated about 99% effective.
Reproductive-health advocates say the device, which is approved by the Roman Catholic Church, will help to fill a need in the U.S. for a wider array of natural family-planning methods.
The percentage of U.S. women who use natural family planning such as periodic abstinence, withdrawal or the rhythm method hovers in the single digits. These methods are notorious for their high failure rates.
“Here we’re bringing rather rough techniques into the Space Age where we can calculate what days a woman might be at risk,” said Dr. Anita Nelson, associate professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center and principal investigator for the U.S. trials. “What’s very important about this system is the yellow light. Here, women get a more precise reading on those ‘I don’t know’ days.”
What’s unclear is how U.S. couples will receive a system that requires daily monitoring. Americans tend to be inconsistent in their contraceptive use, perpetuating one of the highest unplanned-pregnancy rates in the developed world, with more than half of the babies born in the U.S. unplanned.
“The truth about methods of natural family planning is that they work well if they are used correctly and consistently,” said James Trussell, director of the Office of Population Research at Princeton University. “But they are unforgiving for imperfect use.”
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Industry watchers say it’s tough to predict who would be most likely to use the new device, adding it’s more important to have a wide variety of options on the market than to try to develop a method that will appeal to all couples.
“We need lots of methods that are available to all women for what they need at each point in their lifetimes,” said Susan Tew, a spokeswoman for the Alan Guttmacher Institute, a research arm of Planned Parenthood. “We don’t have enough choices.”
The Persona starter pack, including the monitor and the first 16 urine tests, retails in the United Kingdom for $75. Monthly refills containing eight urine tests go for about $15 there.
Unipath is looking for couples in long-term relationships to participate in the U.S. trials. Half the trial participants in each city will be chosen at random to use condoms, while the other 50% will use the monitor. Couples will be asked to chart their sexual activity and to report back to Unipath for 13 months.
In addition to Los Angeles and San Francisco, trials are being held in New York, Milwaukee, Atlanta, Dallas, Indianapolis, Tampa and Washington, D.C.
Unipath expects to submit data from the trials to the Food and Drug Administration as part of its application to put the monitor on the market here. If the monitor receives FDA approval, Unipath anticipates it will appear in U.S. stores in 2000 at the earliest.
* The Los Angeles trials are being conducted by the California Family Health Council. For more information, call (888) UNIPATH.
