FDA Approves New Monthly Injectable Contraceptive, Giving Women A Long-lasting Birth Control Option
JACKSONVILLE, Fla.— University of Florida researchers say a new birth control method approved late Thursday (10/5/00) by the U.S. Food and Drug Administration provides women with a convenient, long-lasting method of contraception.
The product, developed and soon to be marketed under the trade name LUNELLE by Pharmacia Corp. of Peapack, N.J., can prevent pregnancy for up to 30 days with one injection.
In nationwide clinical trials led by Dr. Andrew Kaunitz, a Jacksonville-based University of Florida obstetrician-gynecologist, no unintended pregnancies occurred among 782 women who used the monthly injectable for one year (13 treatment cycles).
The product works to prevent pregnancy the same way that the oral contraceptive method known as the pill does — by blocking ovulation.
Kaunitz, who directed the Phase III (final stage) human trials in 1997 and 1998, said all of the women enrolled in the study were followed medically for 60 weeks after receiving their initial birth control shots. “This hormonal compound, containing estrogen and progestin, is the first new contraceptive option to be made available to American women in more than eight years,” said Kaunitz, professor and assistant chairman of the department of obstetrics and gynecology at the UF College of Medicine. The college is based in Gainesville, but also has faculty at its affiliated campus in Jacksonville.
“The U.S. clinical trials in volunteer women of reproductive age — at 42 clinical sites around the country — revealed the injectable compound provides both the convenience and effectiveness of a long-acting contraceptive,” Kaunitz added.
None of the participants discontinued the monthly injections due to severe adverse effects, according to Kaunitz and project co-director Dr. Lee Shulman of the University of Illinois in Chicago.
Research participants included 20 women from the Duval County region. Jacksonville was the only study site in North Florida.
“Outcomes of this comparative clinical trial also showed that side effects of LUNELLE were very similar to the side effects associated with standard low-dose oral contraceptives that must be taken once every day to prevent pregnancy. In addition, as with oral contraceptives, women using the new monthly injectable contraceptive experienced regular menstrual cycles,” Kaunitz said.
Nationwide data from the trials show that 84 percent of women receiving the injectable contraceptive reported “very” or “somewhat” favorable opinions of the method; 87 percent reported they had no difficulty with returning to their physician’s office for injections, and 90 percent said they would recommend the product to a friend.
Results of the clinical trials appear in the journal Contraception (Vol. 60 published in the fall of 1999) in an article authored by Kaunitz, Roger J. Garceau, Matthew A. Cromie and the LUNELLE Study Group.
Despite the availability of many contraceptive options in the United States, about half of pregnancies are unplanned — adding up to about 3 million unplanned pregnancies in the nation each year, according to Kaunitz and Shulman. Their hope is that the newly approved injectable drug will provide a safe, convenient form of contraception.