Barbara Boughton

May 30, 2012

May 30, 2012 (San Diego, California) — A new phase 3 study of a low-dose estrogen and levonorgestrel contraceptive patch (AG200-15; Agile Patch, Agile Therapeutics) reveals similar safety and efficacy to low-dose oral contraceptives, according to researchers here at the American Congress of Obstetricians and Gynecologists (ACOG) 60th Annual Clinical Meeting.

The open-label randomized multicenter phase 3 study included more than 1500 women who were randomly assigned to either the Agile patch or a combination oral contraceptive containing 20 μg estradiol and 0.1 mg levonorgestrel.

On the basis of this trial and other pharmacokinetic data, the manufacturer has submitted a new drug application to the US Food and Drug Administration for review. Agile Therapeutics anticipates that agency approval of its contraceptive patch would occur in the first quarter of 2013 at the earliest, a company spokesperson said.

"There's a real need for a lower-estrogen birth control patch," lead investigator Andrew M. Kaunitz, MD, associate chair and professor in the Department of Obstetrics and Gynecology at the University of Florida, Gainesville, said at the meeting here.

"This is a pivotal phase 3 clinical trial, because we showed that the patch can be as effective as low-dose oral contraceptives after 1 year. It was wearable, rarely causing irritation, and women were more likely to use the patch without errors than birth control pills. The new Agile patch will be a welcome addition to contraceptive options for my patients," Dr. Kaunitz said.

Women in the study who were randomly assigned to the Agile patch used their birth control method for 13 cycles, whereas those initially randomly assigned to oral contraceptives switched to the patch after 6 cycles. The study enrolled women with a wide range of body mass indexes, mirroring the American female population. More than 68% of women in the trial had no history of hormonal contraceptive use.

There was no clinically relevant difference in the rate of pregnancy among users of the Agile Patch compared with those who used combination oral contraceptives. The rate of breakthrough bleeding during use of both the patch and oral contraceptives was also similar, although more women on the patch experienced breakthrough bleeding during the first cycle (P = .011).

Patients on the Agile patch missed birth control days during 10% of their menstrual cycles, yet women receiving the combination low-dose contraceptives were more likely to forget to take their pills and missed days during 20% of their menstrual cycles.

"Although breast tenderness has been a concern with earlier hormonal patches, our study showed little difference in this side effect, which was reassuring," Dr. Kaunitz said.

Some of the most common adverse effects seen from use of the Agile patch in the phase 3 trial were headache and nausea, although neither of these adverse effects were more common in patch users than in women who took oral contraceptives.

There were 3 serious adverse events for women on the Agile patch during the 1-year trial, including 1 episode of serious depression and 1 venous thromboembolic event in a female weightlifter, Dr. Kaunitz said. One woman who had previously demonstrated vomiting with hormonal contraceptives vomited while on the Agile patch, he noted.

"These are very respectable data and very reassuring," commented Susan Richman, MD, MPH, an associate clinical professor in the Department of Obstetrics and Gynecology at Yale School of Medicine in New Haven, Connecticut.

"Someday, contraceptive pills will be obsolete," she noted. "Try as women might, their ability to take the same contraceptive pill day in and day out is very limited. The data we have indicates that about half of those on birth control pills discontinue this method during the first 6 months," Dr. Richman said.

"We know that efficacy is better with the birth control patch and the ring because they're user-independent. So any new development in this area is exciting," Dr. Richman added.

Dr. Kaunitz has disclosed receiving research funding from Agile, Teva, Bayer, Medical Diagnostic Laboratories, Noven, and Endoceutics. He is also a consultant to Agile, Teva, Bayer, Merck, and Noven and is a stockholder in Becton Dickinson Royalties: UptoDate. Dr. Richman has disclosed no relevant financial relationships.

American Congress of Obstetricians and Gynecologists (ACOG) 60th Annual Clinical Meeting: Abstract 5. Presented May 7, 2012.

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