A Shot in the Arm for Birth Control--Maybe

Women who need protection from pregnancy but can’t find the right contraceptive might soon have another option.

While not expected to make a big splash, the monthly injectable contraceptive called Lunelle may at least make a ripple in the country’s high rate of unintended pregnancies. Almost half of all pregnancies are unintended, and surveys show consumers are largely dissatisfied with their birth control options.

And although Lunelle will require a monthly trip to the doctor’s office for a shot, the method holds the promise of eventually becoming the first long-acting contraceptive that can be administered by women in the privacy of their homes.

Pharmacia & Upjohn, the maker of Lunelle, has applied to the Food and Drug Administration to market the contraceptive. Approval is anticipated later this year, possibly in the fall.

Lunelle is expected to attract women who may currently use the only other injectable, Depo-Provera, or those who aren’t dedicated to a single method.

“It’s an incredibly effective birth control method. And it’s entirely reversible,” says Dr. Andrew M. Kaunitz, a professor of obstetrics and gynecology at the University of Florida Health Sciences Center in Jacksonville.

In a one-year study of 700 American women, Lunelle was found to be 100% effective in preventing pregnancy, with few side effects. Kaunitz, the lead investigator of the study, presented the research last week at the annual American College of Obstetricians and Gynecologists meeting in Philadelphia. Lunelle is already in use in many other countries, including Mexico.

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At first glance, there would seem to be little about Lunelle to attract women. While Depo-Provera involves an injection every three months, Lunelle requires a woman to go to a doctor’s office or clinic every 28 days for a shot.

However, health experts say Lunelle is a very different product than Depo-Provera and offers unique advantages that may appeal to some women.

Unlike Depo-Provera, which contains only a synthetic progesterone, Lunelle contains both estrogen and progestin, similar to an oral contraceptive.

Thus, the side effects associated with Lunelle may be better tolerated by women because of the combination of hormones.

“I think Lunelle will attract a completely different group of women,” says Dr. Anita Nelson, an associate professor of obstetrics and gynecology at Harbor-UCLA Medical Center and one of the investigators in the Lunelle study. “I see this as a good method for women who don’t like the side effects with Depo-Provera. And I see this as a good method for pill users because it’s the same mix of hormones and gives women a controlled menstrual cycle. It also takes away the angst of remembering to take the pill.”

Oral contraceptives, which are the choice of about 27% of all contraceptives users, are virtually 100% effective if taken every day. But many women miss pills each month, raising the overall failure rate of the method to about 5% in the United States.

“Pregnancies are common in pill takers who are not perfect pill takers,” says Kaunitz. “The injectable transcends this problem. In our study, we did not see any pregnancies. Among the comparison group--300 women using birth control pills--we saw two pregnancies.”

Depo-Provera, while also highly effective, often causes irregular bleeding or spotting in women. Depo-Provera also takes several months to “wear off” before a woman can become pregnant; Lunelle offers a quicker return to fertility, Nelson said.

Depo-Provera is also associated with side effects such as headache, weight gain and nervousness. In the data presented last week, the major side effect associated with Lunelle was some initial irregular bleeding in the first month of use before a regular menstrual pattern was established. Lunelle can also cause some muscle soreness at the injection site, which is either the arm or hip.

Bleeding patterns with Lunelle may have to do with how precise a patient is about getting the shot every 28 days, Kaunitz says. There is a 10-day window during which a woman can get the shot and still be protected against pregnancy, although Kaunitz says it’s preferable for a woman to return for her next shot from 25 to 31 days after her last shot.

Even with some flexibility, whether women would want to make a trip to the doctor’s office every month is questionable, some health experts say. Depo-Provera is presently used by about 3% of women, age 15 to 44, who are at risk for pregnancy. And of those, however, most are women 15 to 24, and many of those women don’t stay with the method very long, says Dr. James Trussell of the Princeton University Office of Population Research.

“What has been found with Depo is that the discontinuation rate is very high,” he says. “If people discontinue Depo because it’s inconvenient to get a shot, then that will be a problem [with Lunelle]. If it’s because of weight gain or bleeding problems--and virtually everyone has not-normal bleeding on Depo--neither of these should be a factor with Lunelle.”

The study released last week did not show a problem with women adhering to the injection schedule.

“We had no one drop out because of the inconvenience,” says Kim Bartley, an ob-gyn nurse-practitioner who worked closely with some study participants. “The women see nurses and have access to other health information, and they seem to enjoy the visit.”

Visits for Lunelle are akin to those for allergy shots, says Nelson.

“It’s a nurse-only visit. [Patients] slip in and slip out,” she says.

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Pharmacia & Upjohn has not announced how much Lunelle would cost, although it is expected to be similar to oral contraceptives (about $25 per month). And insurers are expected to cover Lunelle once approved.

Ultimately, the long-term success of Lunelle may depend on whether the manufacturer can make the shot easy enough to give at home--and whether government regulators would allow such a method. The current form of Lunelle requires a deep-muscle injection that can be done only with some medical training.

“Over time, we’re looking at smaller needles and self-administration at home. I think that’s the direction women would like to go with this,” says Kaunitz.

Before then, however, health authorities are likely to explore other avenues--such as whether Lunelle could be given by nurses at school campuses or college health clinics or even by pharmacists. “It could be given by nurses wherever the community allows,” Nelson says.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Contraceptive Options

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Method / Effectiveness* Percentage of users Percent use Average use Tubal sterilization / 27.7% 0.5 0.5** Pill / 26.9% 0.1 6.0 Male condom / 20.4% 3.0 16.0 Vasectomy / 10.9% 0.1 0.2** Withdrawl / 3% 4.0 24.0 Injectable (Depo-Provera) / 3% 0.3 0.4 Periodic abstinence / 2.3% 9.0 19.0 Diaphragm / 1.9% 6.0 18.0 Implant (Norplant) / 1.3% 0.05 0.05 IUD / 0.8% 0.8 4.0 Others*** / 1.8% -- --

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* Percentage of failures leading to pregnancy

** In rare occurances, surgery fails

*** Includes spermicide and the female condom

Source: Planned Parenthood Federation of America