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

Autor: Nelson AL; Essential Access Health, Los Angeles, CA, USA. Electronic address: AnitaLNelson1@gmail.com., Kaunitz AM; University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA., Kroll R; University of Washington, Seattle Women's Health, Research, Gynecology, Seattle, WA, USA., Simon JA; George Washington University School of Medicine, Washington, DC, USA., Poindexter AN; Advances In Health, Inc., Houston, TX, USA., Castaño PM; Columbia University Irving Medical Center, New York, NY, USA., Ackerman RT; Comprehensive Clinical Trials LLC, West Palm Beach, FL, USA., Flood L; ALK-Abello, Inc. Pharmaceuticals, Bedminster, NJ, USA., Chiodo JA 3rd; Agile Therapeutics, Inc., Princeton, NJ, USA., Garner EI; ObsEva, One Financial Center, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Contraception [Contraception] 2021 Mar; Vol. 103 (3), pp. 137-143. Date of Electronic Publication: 2020 Nov 28.
DOI: 10.1016/j.contraception.2020.11.011
Abstrakt: Objective: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA Ⓡ ) containing levonorgestrel (LNG) and ethinyl estradiol (EE).
Study Design: 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.
Results: The study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m 2 . 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 <30 kg/m 2 and 8.6 (5.8-11.5) in women with BMI ≥30 kg/m 2 . Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m 2 ) reported thromboembolic events considered related to treatment.
Conclusions: The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m 2 . The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLA Ⓡ for prevention of pregnancy in women with BMI <30 kg/m 2 .
Implications: TDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m 2 . TDS has reduced effectiveness in women with BMI ≥30 kg/m 2 .
(Copyright © 2020. Published by Elsevier Inc.)
Databáze: MEDLINE
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