Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

• Published in: Contraception (Stoneham) 2021-03, Vol.103 (3), p.137-143
• Main Authors: Nelson, Anita L, Kaunitz, Andrew M, Kroll, Robin, Simon, James A, Poindexter, Alfred N, Castaño, Paula M, Ackerman, Ronald T, Flood, Lisa, Chiodo, Joseph A, Garner, Elizabeth IO
• Format: Article
• Language: English
• Subjects: Adolescent; Body Mass Index; Combination hormonal contraceptive; Contraceptive patch; Contraceptives, Oral, Combined; Estradiol; Ethinyl estradiol; Ethinyl Estradiol - adverse effects; Female; Humans; Levonorgestrel; Levonorgestrel - adverse effects; Phase 3 trial; Pregnancy; Transdermal
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2020.11.011

To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLAⓇ) containing levonorgestrel (LNG) and ethinyl estradiol (EE). This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used. The study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m2. In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5–7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9–5.8) in women with BMI