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New Innovations, Methods Improving on `the Pill'

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DALLAS - Many women soldiers are carrying large quantities of birth control pills to Iraq, hoping that by taking the pill continuously they can eliminate their monthly periods while they fight a war.

It's not a new idea for how to use the pill, says Andrew Kaunitz, a Florida obstetrician-gynecologist who has written birth control prescriptions for some of the soldiers.

"It comes down to a lifestyle choice for women who, due to a job or recreational reasons, prefer to bleed less often," he says of the practice. "Female soldiers in a desert setting with a lack of sanitary supplies would have a good reason to suspend menstruation indefinitely."

Women have been manipulating their menstrual cycles for years, either hoping to prevent pregnancy or to control their monthly discomfort. But the decision to use the Pill nowadays is no longer so easy, or so automatic.

Not only are there more than 40 kinds of pills on the market today, but women shopping for birth control face even more options. In the past two years, the birth control menu has grown to include the vaginal contraceptive ring (NuvaRing), a new monthly injection (Lunelle) and the contraceptive patch (Ortho Evra).

And earlier this month, the U.S. Food and Drug Administration approved the latest idea for female contraception: an oral contraceptive called Seasonale that is taken for 84 consecutive days, allowing women to limit their periods to just four times a year.

"Everybody wants something different," says Dr. Paul Blumenthal of Johns Hopkins University. "If we only had the pill, we know it's a pretty safe and effective method. But every tweak in contraceptive methods is aimed at meeting people's needs and improving compliance."

Almost since it came onto the market in 1960, oral contraception has been the favored form of reversible birth control for millions of American women. This year alone, an estimated 16 million American women will spend $2.8 billion on this method, according to the pills' manufacturers.

Researchers, and the pharmaceutical companies they work for, however, are exploring the scientific benefits of newer methods of birth control in hopes of encouraging women to try something different.

The primary dispensers of birth control, including Planned Parenthood Federation of America, are embracing the idea of contraceptive diversity.

"Our philosophy is that there isn't one method that works for all of us," says Patrice Leger, director of medical services for Planned Parenthood of North Texas, the area's largest dispenser of birth control. "Women have different health issues, different lifestyles and different plans for future pregnancies."

Women used to follow their doctor's recommendation about what method is right for them. Now they're more likely to ask a friend or to try several versions before picking one, says Dr. David F. Archer, a professor of obstetrics and gynecology at Eastern Virginia Medical School in Norfolk.

"You have to talk about it with other women," agrees Kori Williams, a 20-year-old junior at Southern Methodist University. "Women have to be proactive in this situation."

Often, such discussion comes down to a comparison between the pill and newer methods. Opinions are strong, even among women who aren't using birth control yet.

"The patch makes more sense than the pill," says Henriette Mathis, a 17-year-old SMU freshman, who stresses that she hasn't needed to use either method yet. But she has done her birth control homework nonetheless.

"It would be too hard to remember to take the pill every day," she says. "Changing a patch once a week would be so much easier."

Typically, pill users take a daily dose of a hormone combination of estrogen and progestin for 21 days followed by seven days of inactive pills, such as iron or a placebo.

"The pill is still Number 1 because it's very effective, very easy to take and very tiny to swallow," said Leger of Planned Parenthood. "The most common side effects are minor headaches, breast tenderness and nausea. And a lot of these things go away if you continue to take it."

The pill also has been associated with such benefits as menstrual regularity and a reduction in blood flow, pain and iron loss.

Since the pill and most other birth control methods boast low failure rates - less than 1 percent - women are being encouraged to weigh other factors in making their choices. The pill's greatest flaw is that it gives women a daily opportunity to forget to take it.

Various studies have reported that from 19 percent to 47 percent of oral contraceptive users missed one or more pills per 28-day cycle.

"The real failure rate of the pill is 5 percent," says Blumenthal, an associate professor of gynecology and obstetrics at Johns Hopkins. By his calculation, every percentage point of pill failure results in 100,000 unintended pregnancies in the United States.

The failure risk associated with the pill makes the search for easier-to-use birth control devices even more compelling, notes a recent study on the new birth control patch, Ortho Evra, published in the journal Fertility and Sterility. Archer, a longtime birth control researcher and co-author of that study, calls the new birth control patch particularly "forgiving" compared with the pill. Women who forget to change their patch every seven days, as directed, may still get up to three days of additional hormonal protection.

The study compared the size of an ovarian follicle, which contains the developing egg, in women who were instructed to wear the patch for 10 days instead of seven and in women who forgot to take their birth control pills for three consecutive days.

Following the dosing error, women using the patch experienced "a significantly lower rate of ovulation" than those on the pill, the study concluded. Johnson & Johnson Pharmaceutical, maker of the patch, funded the study, which involved 124 women.

But when choosing a birth control method, personal experience may trump science. The various side effects of any method would seem more likely to dictate whether or not women continue to use it.

One SMU freshman, who asked not to be fully identified, says she stopped using the patch last spring because she was experiencing headaches. "I quit after two months," said 18-year-old Tori. "Now I'm getting (Depo-Provera) shots every three months. It's working great."

But a 17-year-old classmate couldn't be happier with the patch. "My breasts got bigger," says Brittany, who also did not want her full name used. "I gained 10 pounds, but it was kind of proportional."

Conversely, the lack of side effects could be an issue for Seasonale, which was developed by Barr Laboratories as the first oral contraceptive intended to reduce the number of menstrual cycles. The drug is designed to drop a woman's periods from the typical 13 per year to just four. The method is likely to raise questions about whether or not women should suppress their "natural cycle." The case against Seasonale could build on criticism of the way the menstrual cycle has been manipulated for decades by other forms of birth control.

"Tampering with the hormonal climate of healthy menstruating women, including teenage girls whose lives stretch ahead for decades, for the purpose of doing away with their periods is, in a word, reckless," writes Susan Rako in her new book, "No More Periods."

However, the possibility of fewer monthly headaches, cramps and bleeding seemed to be a powerful attraction to the women who participated in Seasonale's clinical trials, said several researchers involved in the study.

"Normally, it can take months to recruit appropriate and motivated volunteers for a clinical trial," says Kaunitz, a professor of obstetrics and gynecology at the University of Florida Health Science Center in Jacksonville. "For this one, our researchers and nurses were flooded with calls."

The randomized multicenter Seasonale trial ended in March 2002 and involved approximately 1,400 women ages 18 to 40. The product is no more than a repackaging of standard birth control pills, using them in a new way, he notes of the instructions to take the pills for 84 days straight, followed by a week of placebo pills.

Still, the FDA extended Seasonale's review for a second year in order to track a higher-than-expected incidence of breakthrough bleeding by some subjects in the first six months of the study.

"The majority of women who had breakthrough bleeding actually had spotting that wasn't a serious problem," says Carol Cox, vice president of corporate communications for the manufacturer. "When you just start on oral contraceptives, it's not uncommon to have breakthrough bleeding."

While Seasonale takes a different tack on birth control, many doctors already are prescribing continuous use of regular birth control pills to delay menstruation, says Dr. Patricia Sulak, a professor of obstetrics and gynecology at Texas A&M University's College of Medicine.

"It's a treatment for endometriosis and for women who have horrible cramps with their periods," she says.

Sulak has concluded from her independent research into contraceptive methods that taking birth control pills on a monthly schedule causes many of the adverse symptoms associated with menstruation.

"We're artificially inducing these symptoms," she says of cramps, headaches and even premenstrual syndrome experienced by women on the pill. She believes women will be eager to dispense with their monthly cycles.

Of Seasonale's market potential, Sulak predicts, "it's going to be huge."



Devices and substances have been used for thousands of years in an effort to block pregnancy. Here are some key points in the history of contraception:

In ancient times

Condoms (depicted as far back as a cave painting some 12,000 years old) were in use. So were plugs of grass, moss or many other substances; sea sponges; amulets, herbs, ointments and bizarre potions. Abstinence, especially for women, was expected in many cultures to ensure paternity after marriage.

19th century

Condoms began to be manufactured in the United States in the 1840s, by Charles Goodyear, who patented rubber. The Voluntary Motherhood Movement in 1870s America encouraged abstinence for birth control within marriage.

Early 20th century

Condom use became widespread after World War I, mainly to prevent sexually transmitted diseases.

Birth control crusader Margaret Sanger distributed diaphragms, which her husband imported and shipped to her under cover because of U.S. laws suppressing dissemination of contraceptive devices.

Mid 20th century

The oral contraceptive was introduced in 1960. The first pill wasn't perfect, but it gave millions of women an unheard-of control over reproduction. Over the next several decades, newer versions of diaphragms, sponges, intrauterine devices (IUDs), female condoms and other means of birth control came onto the market.


The newest products include a monthly injection, a patch that delivers hormonal protection for a week at a time, and - soon - an oral contraceptive designed to limit periods to four a year.

-Sources: Planned Parenthood Federation of America; Dallas Morning News research



Women have more birth control choices than ever before. Some of the newer forms available by prescription include:

Depo-Provera, an injection given every three months that can suspend monthly periods. Can also cause irregular bleeding, weight gain and other mild to moderate symptoms.

Lunelle, an injection given every 28 days, with five days off, followed by another injection. Requires a monthly doctor visit and can cause weight gain and alter the menstrual cycle.

NuvaRing, a 2-inch, flexible ring inserted into the vagina for three weeks and removed for one week. Can cause vaginal discharge.

Ortho Evra, a 2-inch patch applied to abdomen, buttocks, upper outer arm or upper torso for seven-day intervals over three weeks, with one week off. May cause rash.

Preven and Plan B, pills that must be taken within 72 hours of unprotected intercourse. Can reduce pregnancy risk by almost 80 percent but may cause nausea, vomiting and abdominal pain.

Seasonale, pills taken daily for 84 days followed by seven placebos. Can cause breakthrough bleeding. Available in late October.

-Sources: U.S. Food and Drug Administration; Dallas Morning News research


(c) 2003, The Dallas Morning News. Distributed by Knight Ridder/Tribune News Service.

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