NYMC Faculty Publications

Safety and Tolerability of a New Low-Dose Contraceptive Patch in Obese and Nonobese Women

Author Type(s)

Faculty

DOI

10.1016/j.ajog.2014.09.014

Journal Title

American Journal of Obstetrics and Gynecology

First Page

1

Last Page

8

Document Type

Article

Publication Date

3-1-2015

Department

Medicine

Keywords

Adolescent, Adult, Contraceptives, Oral, Combined, Contraceptives, Oral, Hormonal, Drug Combinations, Ethinyl Estradiol, Female, Humans, Levonorgestrel, Norgestrel, Obesity, Patient Outcome Assessment, Transdermal Patch, Young Adult

Disciplines

Medicine and Health Sciences

Abstract

OBJECTIVE: The safety and tolerability of a new low-dose levonorgestrel/ethinyl estradiol (LNG/EE) contraceptive patch was compared with 2 combination oral contraceptives in 2 clinical studies in which approximately 30% of enrolled participants were obese.

STUDY DESIGN: Two phase 3, open-label, randomized, parallel-group, multicenter trials compared the LNG/EE contraceptive patch (n = 1579) with combination oral contraceptives (n = 581) in healthy women 17-40 years of age. Combination oral contraceptives were LNG 100 μg per EE 20 μg (combination oral contraceptive 20; n = 375) or LNG 150 μg per EE 30 μg (combination oral contraceptive 30; n = 206). Safety and tolerability data from the 2 trials were evaluated in integrated safety analyses.

RESULTS: Treatment-emergent adverse events of 2% or greater in the LNG/EE contraceptive patch were nasopharyngitis (5.2%), nausea (4.1%), upper respiratory infection (3.5%), headache (3.4%), sinusitis (2.9%), cervical dysplasia (2.3%), and urinary tract infection (2.1%). Including skin reaction-related treatment-emergent adverse events, the proportion of women who experienced any treatment-emergent adverse event was similar among women randomized to the contraceptive patch (47.5%), the combination oral contraceptive 20 (47.4%), or the combination oral contraceptive 30 (46.8%). The incidence of treatment-emergent adverse events was similar in obese vs nonobese participants in all groups. Serious adverse events occurred in less than 1% of participants in any of the treatment groups.

CONCLUSION: The LNG/EE contraceptive patch and combination oral contraceptives were well tolerated and associated with similar treatment-emergent adverse event incidences in obese and nonobese women.

Link to Full Text

Share

COinS