The Pharmacia Corporation announced
today that the U.S. Food and Drug Administration (FDA) approved Lunelle ®
Monthly Contraceptive Injection (medroxyprogesterone acetate and estradiol
cypionate injectable suspension), the first and only once-a-month
contraceptive option for women in the U.S. Lunelle, a combined hormonal
injectable contraceptive method, has contraceptive benefits similar to the
pill yet offers women the convenience of once-a-month dosing.
"I think Lunelle is going to meet a big need for women in this country --
it has contraceptive benefits similar to the pill yet is administered only
once a month," said 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."
Lunelle was approved based on data from a pivotal clinical study of 1,103
women that compared the efficacy, safety and patient acceptability of Lunelle
versus Ortho-Novum 7/7/7(R), a leading oral contraceptive, at 42 sites in the
U.S. The data reported no unintended pregnancies among the 782 women taking
Lunelle versus two unintended pregnancies among the 321 women using the oral
contraceptive after 15 cycles of use.
"With my busy schedule, I find Lunelle easier than taking a pill every
day. I'm out of my health care provider's office in less than 15 minutes once
a month," says Roslyn Tate, a clinical study participant.
Lunelle contains a combination of the hormones progestin and estrogen that
is similar to the body's natural hormones. It is recommended that Lunelle be
administered every month by a health care provider, not to exceed 33 days, as
a single, small 0.5ml monthly intra-muscular injection. The estrogen in
Lunelle is metabolized to 17 beta-estradiol - the body's natural estrogen -
and at peak levels does not exceed a woman's natural cyclic levels of
Lunelle ® Monthly Contraceptive Injection provides monthly menstrual
cycles and a quick return to ovulation, usually within two to four months.
More than 50 percent of the users became pregnant during the first six months
following discontinuation of Lunelle.
As with the use of contraceptives containing estrogen and progestin,
Lunelle is not appropriate for some women, 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; and undiagnosed abnormal genital bleeding. The use of
contraceptives containing estrogen is associated with an increased risk of
cardiovascular side effect, which increases with heavy smoking and age,
especially women over 35. Women using Lunelle are strongly discouraged from
smoking. Like other hormonal contraceptives, women may experience altered
bleeding patterns when using Lunelle. The average weight gain of women in the
U.S. clinical trial over one year on Lunelle was four pounds. In addition,
Lunelle does not protect against HIV and other sexually transmitted diseases.
For more information on Lunelle ® Monthly Contraceptive Injection and
Pharmacia Corporation, please contact us at 1-888-691-6813. For physician and
pharmacist information on Lunelle ®, please call 1-800-253-8600,