BBI Contributing Editor

LOS ANGELES, California — For the first time, women have a birth control option they only need to think about once a week or once a month. The introduction of birth control pills into the U.S. 42 years ago seemed like a huge option then — and now even more options are becoming available to women, such as how often to re-apply the birth control method and whether or not to have monthly menses. Several new contraceptive options for women have recently been approved by the FDA, including a monthly injection, a monthly vaginal ring and a weekly transdermal patch. These new reversible forms of birth control were presented, along with updates on the estrogen-impregnated IUD and advances made in male contraception, at a press conference held during the annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington) held here early last month.

David Plourd, MD, assistant professor of obstetrics and gynecology at the Naval Medical Center (San Diego, California), discussed the latest research developments and current clinical practices in contraception. When birth control pills were initially used, they were associated with risks such as increased strokes; but today's pills are actually a healthy method of contraception. Birth control pills today promote better health for their users, providing them with denser bones, lighter and less painful monthly periods, and fewer incidences of pelvic inflammatory disease. The high rates of unintended pregnancies with the reversible methods of contraception created the need for longer-lasting methods of birth control that do not require daily compliance, the biggest cause of failure. Not until now — 10 years since the last new product — have any new methods of birth control been introduced that address this need for less compliance-dependent methods (see Table 1).

Table 1:
Timeline of Reversible Contraceptive Methods
U.S. Introduction Product Comments

1839 Rubber condoms Goodyear's "other" discovery
1868 Forerunner of first IUD
1960 Birth control pills Rapid market acceptance
1972 Dalkon Shield IUD Many problems, resulting in lawsuits and removal of product from market
1988 Paraguard, a long- acting IUD Problems related to the Dalkon Shield in the 1970s foreshadowed its acceptance; now slowly gaining appeal; effective for 12 years
1988 Cervical cap First one FDA-approved; barrier method only
1990 Norplant Implantable, reversible, lasts five years; had initial explant problems
1992 Depo-Provera Injectable every three months; weight gain undesirable for many
1998 Preven Emergency contraception taken within 72 hours of unprotected sex
1999 Plan B Emergency contraception
2000 RU486 (Mifeprex) Pill that induces early abortion
2001 Mirena IUD that slowly releases progestin; lasts five years
2002 Lunelle Monthly injection of combination hormones
NuvaRing Monthly vaginal ring with slow release of combination hormones
Ortho EVRA Weekly patch with transdermal release of combination hormones

Sources: Medical Market Information, The BBI Newsletter

This year marks the 10th anniversary of Depo-Provera from Pharmacia (Peapack, New Jersey) the injectable progestin-only contraceptive that is administered every three months. According to Plourd, the teenage pregnancy rate decreased significantly after the introduction of Depo-Provera. However, two issues have limited its widespread use: The lack of periods and weight gain. Many patients who are sexually active want a monthly period to know if they are pregnant or not; and others feel as though it is unhealthy not to have a period. In addition to these emotional rationale, the associated weight gain — frequently about 10 pounds — acts as a deterrent to its use.

Three new forms of birth control aim at decreasing the opportunity for compliance failure, without the associated side effects of Depo-Provera. They require either weekly or monthly applications (compared to a daily pill), and in case the patient forgets to change the application at the appropriate time, there is a built-in cushion of two to nine days where the patient remains protected from pregnancy. All three new methods contain a low dose of combination hormones progestin and estrogen for a slow release, steady-state delivery, and all three are virtually comparable in side effects and efficacy, Plourd said.

The Ortho EVRA birth-control patch from McNeil Pharmaceutical (Raritan, New Jersey) is currently available by prescription and is worn seven days, then replaced with a new patch weekly except for the 4th week when menses occurs. The first-of-its-kind patch, with transdermal hormone delivery, combines the effectiveness of the Pill — 99% when used correctly — with convenient once-a-week-dosing. In a poster presentation, Dr. George Creasy, MD, of the R.W. Johnson Pharmaceutical Research Institute (also Raritan). showed that compliance with EVRA was superior to adherence to birth control pill regimens and stated that improved compliance may be associated with a lower rate of pregnancy due to user failure.

The NuvaRing by Organon (West Orange, New Jersey), has already been approved by the FDA for use in the U.S., but will become widely available this summer. Based upon a new drug delivery system, the combination low dose of progestin and estrogen is released steadily to prevent pregnancy on a monthly basis. The exact positioning of the ring within the vagina is not critical because it is not a barrier contraceptive and therefore cannot be incorrectly inserted. Although Plourd said he feels that the NuvaRing provided the best menstrual cycle control of the three new methods, some patients are hesitant to try it for fear that it will dislodge and lose its effectiveness, or be uncomfortable during sexual relations. The NuvaRing will be the first product attempting to gain FDA approval for continuous use (which eliminates monthly menstrual periods), although many physicians allow their patients to do this off-label with other products as well.

The Lunelle monthly injection from Pharmacia is a combination of hormones delivered intramuscularly by a nurse. In the future, it is hoped that it can be self-delivered subcutaneously. Lunelle has gained rapid acceptance, in part due to patient's perception that it can't fall off or out of the body like a patch or ring could be perceived to do. And unlike Depo-Provera, only a mild weight gain — usually five pounds or less — has been noticed by most patients.

All three of these new forms of reversible birth control are monophasic, and Plourd said he felt that most physicians will allow their patients continuous use if requested. Continuous use means that the patient doesn't stop treatment for a week to allow for menses to occur, but instead continues the dosage — whether it be by patch injection, or ring — and therefore does not have monthly periods, offering even more options for women who only 42 years ago were first allowed to control their own fertility. As the old Virginia Slims motto held: We have come a long way, baby!

Some 14,000 pregnancies result from sexual assault every year, but only one-third of hospitals routinely offer emergency contraception to the victims. At last year's meeting, ACOG members were encouraged to offer a prescription for emergency contraception to every woman of childbearing age during their annual pap smear exam. Emergency contraception is an option that should be acceptable to both sides of the abortion conflict, since it is a method that prevents abortion but does not terminate an existing pregnancy.

Of all the options available, the IUD has been proven to be the most effective reversible form of birth control, with a better than 99% effectiveness. Although many factors are in play, one key factor lending itself to effectiveness is the fact that the silastic creates a sterile inflammatory response that thickens the cervical mucous, creating a road block to sperms and germs. Contrary to popular belief caused by the Dalkon Shield in the 1970s, current IUDs do not cause infertility, and actually help prevent pelvic inflammatory disease from occurring. The IUD is the most cost-effective method of birth control and has been touted as the best method for the underprivileged, saving taxpayers $114,125 for each IUD placed. In addition to being the most effective both in cost and control, the Mirena IUD from Berlex Laboratories (Montville, New Jersey) has the added benefit of reducing menstrual flow by 70% to 90%, and in about 20% of its users, creating amenorrhea.

On the horizon is Implanon by Organon (Oss, the Netherlands), a new single-rod contraceptive implant that takes only minutes to insert and remove. It offers women the convenience of highly effective contraceptive protection for three years. Although many birth control pills are being used off-label in a continuous manner in order to avoid monthly periods, Seasonelle is going to be offered soon that will be labeled for continuous use, allowing for menses only four times a year. On the male horizon, male hormonal contraception that reduces sperm count, and is reversible, is in Phase II trials. It will be interesting to see how well men perform in terms of compliance when their "pill" is on the market.

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