FDA Approves Monthly Contraceptive Injection
Women now have another choice in contraception. On October 5, 2000 the Food and Drug Administration (FDA) approved Lunelle™ Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension). Lunelle is the first once-a-month birth control method available to women in the US. The new contraceptive is a combined hormonal method with benefits similar to oral contraceptives.
The National Association of Nurse Practitioners in Women's Health (NPWH), a national organization committed to assuring the provision of quality health care to women of all ages by nurse practitioners, applauded the FDA's approval of Lunelle welcoming the addition of what they say is a reliable and convenient birth control option that allows women to control their family planning.
According to Susan Wysocki, RNC, NP, NPWH, President and CEO of NPWH, "The continued high unintended pregnancy rate for women in the United States underscores the need for new birth control options that are not tied to daily pill-taking and give American women the flexibility they need. NPWH believes that Lunelle fills a valuable void in birth control. The method, which is effective for a month, means less to remember for women with busy lives."
In a pivotal clinical study, Lunelle was compared with Ortho-Novum 7/7/7® at 42 sites in the United States. The efficacy, safety, and patient acceptability was compared among 1,103 women who participated with 782 women taking Lunelle and 321 women using the oral contraceptive. After 15 cycles, no unplanned pregnancies were reported among the women using the contraceptive injection, while 2 pregnancies occurred in the group using the oral contraceptive.
According to Anita Nelson, M.D., University of California Harbor Medical Center, and U.S. clinical trial investigator, "Lunelle is more than 99 percent effective when administered as scheduled, offering women a reliable and convenient new birth control option."
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The combination of the synthetic hormones progestin and estrogen used in Lunelle are similar to the body's natural hormones. Recommendations are that Lunelle should be administered by a health care provider at intervals not to exceed 33 days. Women who choose this birth control method will receive a single 0.5 ml intramuscular injection monthly. The estrogen in Lunelle is metabolized to 17 beta-estradiol. This is one of the body's natural estrogen. At peak levels it does not exceed a woman's natural cyclic levels of estrogen. |
Who shouldn't use Lunelle?
Certain women should not use Lunelle, including those with:
- known or suspected pregnancy
- current or history of thrombophlebitis or thromboembolic disorders
- cerebral vascular or coronary artery disease
- liver dysfunction
- certain types of cancer
- severe diabetes or hypertension
- heavy smokers over the age of 35
- undiagnosed abnormal genital bleeding
Side Effects
Estrogen use is associated with an increased risk of cardiovascular side effects. This risk increases with age and heavy smoking. The risk is greatest for women over age 35. Women who use any form of estrogen should not smoke to reduce this risk. Other possible side effects that may occur while using Lunelle include irregular bleeding and slight weight gain.
It's important to remember that Lunelle, as well as other contraceptives, does not provide protection against HIV/AIDS or other sexually transmitted diseases. Unless you are in a long-term monogamous relationship you should always use a condom in addition to other methods of birth control to prevent AIDS and other STDs.
Lunelle is trademarked by the Pharmacia Corporation.
More About Contraceptives
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