Low-dose contraceptive patch comparable to combination oral contraceptive in safety, tolerability study

February 28, 2013

A low-dose contraceptive patch is comparable to combination oral contraceptive in a comparative study, according to phase 3 data presented at the American College of Obstetricians and Gynecologists' (ACOG) 60th Annual Clinical Meeting.

 

A low-dose contraceptive patch is comparable to combination oral contraceptive in a comparative study, according to phase 3 data presented at the American College of Obstetricians and Gynecologists’ (ACOG) 60th Annual Clinical Meeting.

A once-weekly, low-dose combination contraceptive patch (AG200-15, Agile) containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG) was evaluated in a diverse population of more than 1,500 women, including obese women, minorities, and new users of hormonal contraceptives. This comparative study demonstrated that AG200-15 has contraceptive efficacy comparable to that of an approved low-dose oral contraceptive comparator, as well as a similar safety and tolerability profile.

“Unlike many contraceptive clinical trials, this study was conducted in a population that reflects all US reproductive-age women,” said Andrew Kaunitz, MD, associate chair and professor of the department of obstetrics and gynecology at the University of Florida. Dr Kaunitz is the principal investigator for the AG200-15 phase 3 trial.

Two additional studies also were presented at ACOG by David F. Archer, MD, professor of obstetrics and gynecology at Eastern Virginia Medical School. The first demonstrated that the investigational patch can be worn on any of the 3 administration sites (abdomen, buttock, or upper torso), without any clinically significant differences in blood levels of the active ingredients, EE and LNG. The second study showed that the patch can be worn under various conditions, including in the whirlpool and sauna, and during vigorous exercise, without any clinically significant difference in blood levels.

The phase 3 AG200-15 data also shows greater compliance than oral contraceptives with study participants having fewer missed days of contraception with the once-weekly patch than with oral contraceptives. Data were presented from 1,328 women, of whom 998 received the patch and 330 received an oral contraceptive. Over the first 6 cycles of the study, the percentage of cycles with perfect compliance was significantly higher in the patch group than in the pill group (90.5% vs 78.8%, P<.001). Additionally, compliance with the patch improved over the 6 cycles, while compliance with the pill worsened.

“Noncompliance among contraceptive users is an ongoing challenge, as the effectiveness of a contraceptive can decrease if it is not used correctly,” Dr Kaunitz said. ■