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Published on: September 20, 2019
Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial.
Andrew M Kaunitz1, David Portman, Carolyn L Westhoff
1Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida; the Columbus Center for Women's Health Research, Columbus, Ohio; Mailman School of Public Health, Columbia University, New York, New York; the Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, Virginia; the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California; ARSTAT, Flemington, New Jersey; and Agile Therapeutics, Inc, Princeton, New Jersey.
A new low-dose contraceptive patch containing levonorgestrel and ethinyl estradiol demonstrated comparable efficacy and safety to a combination oral contraceptive pill. Both methods showed similar compliance and unscheduled bleeding profiles, with the patch being well-tolerated.
Area of Science:
- Reproductive Health
- Contraception
- Pharmacology
Background:
- Hormonal contraceptives are widely used for pregnancy prevention.
- Newer formulations aim to improve user convenience and safety profiles.
- Comparing existing and novel contraceptive methods is crucial for informed clinical choices.
Purpose of the Study:
- To evaluate the efficacy, safety, compliance, and bleeding patterns of a new low-dose levonorgestrel and ethinyl estradiol contraceptive patch.
- To compare these outcomes against a standard combination oral contraceptive pill.
- To assess the tolerability and user experience of the novel contraceptive patch.
Main Methods:
- A randomized trial involving 1,504 women aged 17-40.
- Participants were assigned to either the contraceptive patch or an oral contraceptive pill.
- Efficacy was measured using the Pearl Index, with compliance assessed via plasma drug levels and bleeding/administration recorded daily.
Main Results:
- Pearl Indices were comparable between the patch and pill groups, both for the intention-to-treat and compliant populations (not statistically significant).
- Incidence of unscheduled uterine bleeding and adverse events were similar between the two contraceptive methods.
- Laboratory-verified noncompliance rates were also similar, approximately 11-12.6% at cycle 6.
Conclusions:
- The new contraceptive patch offers comparable efficacy and safety to a combination oral contraceptive pill.
- Both methods exhibit similar compliance and unscheduled bleeding profiles.
- The contraceptive patch is a well-tolerated and viable alternative for women seeking hormonal contraception.
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