NYMC Faculty Publications

Self-Reported and Verified Compliance in a Phase 3 Clinical Trial of a Novel Low-Dose Contraceptive Patch and Pill

Author Type(s)

Faculty

DOI

10.1016/j.contraception.2014.11.011

Journal Title

Contraception

First Page

204

Last Page

210

Document Type

Article

Publication Date

3-1-2015

Department

Medicine

Keywords

Adolescent, Adult, Body Mass Index, Contraceptives, Oral, Combined, Drug Combinations, Ethinyl Estradiol, Female, Humans, Levonorgestrel, Patient Compliance, Reproducibility of Results, Self Report, Transdermal Patch, Young Adult

Disciplines

Medicine and Health Sciences

Abstract

OBJECTIVE: Pregnancy rates in US contraceptive clinical trials are increasing due to decreased treatment compliance. This study compared compliance with a new low-dose levonorgestrel (LNG) and ethinyl estradiol (EE) contraceptive patch (CP, Twirla™) with that of a low-dose combination oral contraceptive (COC) in a demographically diverse population.

STUDY DESIGN: This analysis was part of an open-label, parallel-group, multicenter phase 3 study that randomized healthy sexually active women (17-40years) to 13cycles of LNG/EE CP or 6cycles of COC, then 7cycles of LNG/EE CP. We defined self-reported compliance as cycles that, according to diaries, show 21days of patch wear without missed days or any patch worn >7days or 21days of pill-taking without missed pill days. We verified compliance by detectable plasma presence of LNG and EE at cycles 2, 6, and 13.

RESULTS: Of the intention-to-treat population with diary information (N=1328, mean age 26.4years, 46% minorities, 33% obese), 10.0% of the CP (n=998) versus 21.2% of the COC group (n=330) self-reported noncompliance after 6cycles (p< .001). Laboratory assessments verified 10-14% of participants in both groups as noncompliant. Self-reported perfect use did not vary between obese [body mass index (BMI) ≥30kg/m(2)] versus nonobese (BMI < 30kg/m(2)) participants in both groups or when stratified by age, education, or race/ethnicity in the CP group.

CONCLUSIONS: Self-reported compliance was significantly greater in the CP than COC group and did not vary by obesity status. Discrepancies between self-reported and verified compliance question reliability of patient diaries.

IMPLICATIONS STATEMENT: This paper, based on an analysis of a phase 3 trial, shows that compliance was significantly greater with a new weekly transdermal CP than with a once-daily COC in obese as well as nonobese participants. Discrepancies between self-reported compliance and laboratory-verified compliance raise questions regarding the reliability of patient diaries.

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