Adherence with ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen supported by the use of a digital tablet dispenser with or without acoustic alarm: an open-label, randomized, multicenter study
Authors Wiegratz I, Elliesen J, Paoletti AM, Walzer A, Kirsch B
Received 29 July 2014
Accepted for publication 4 October 2014
Published 5 January 2015 Volume 2015:7 Pages 19—29
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 4
Editor who approved publication: Professor Elie Al-Chaer
Inka Wiegratz,1,2 Jörg Elliesen,3 Anna Maria Paoletti,4 Anja Walzer,3 Bodo Kirsch3
1Kinderwunschpraxis am Goetheplatz, Frankfurt, Germany; 2MVZ Kinderwunschzentrum Wiesbaden GmbH, Wiesbaden, Germany; 3Bayer HealthCare Pharmaceuticals, Berlin, Germany; 4Clinica Ostetrica e Ginecologica, University of Cagliari, Cagliari, Italy
Objective: To evaluate the effect of a digital dispenser's acoustic alarm function on adherence to ethinylestradiol (EE) 20 µg/drospirenone 3 mg in a flexible extended regimen (EE/drospirenoneFlex) among women in five European countries (France, Germany, Italy, Spain, UK) seeking oral contraception.
Study design: Randomized, parallel-group open-label study.
Methods: Women aged 18–35 years received EE/drospirenoneFlex administered in a regimen with cycle lengths of their choice with the aid of a digital pill dispenser over 1 year. In group A (N=250), the dispenser's acoustic alarm was activated (ie, acoustic alarm + visual reminder). In group B (N=249), the acoustic alarm was deactivated (ie, visual reminder only). In addition, the women recorded pill intake daily in diary cards. The primary efficacy variable was the mean delay of daily pill release after the dispenser reminded the woman to take a pill (reference time). Secondary efficacy variables included number of missed pills, contraceptive efficacy, bleeding pattern, tolerability, and user satisfaction.
Results: Dispenser data showed a mean (standard deviation [SD]) daily delay in pill release of 88 (126) minutes in group A vs 178 (140) minutes in group B (P<0.0001). Median (lower quartile, Q1; upper quartile, Q3) number of missed pills was 0 (0; 1) in group A vs 4 (1; 9) in group B (P<0.0001). Diary card results revealed similar trends; however, underreporting of missed pills was evident in both groups. No pregnancies were reported during 424 women-years of exposure. Across the two groups, the mean (SD) EE/drospirenoneFlex cycle length was 51.0 (31.8) days with strong regional differences, and the mean (SD) number of bleeding/spotting days was 50.4 (33.0) days. EE/drospirenoneFlex was well tolerated, and 80% of women were satisfied with treatment.
Conclusion: The dispenser's activated acoustic alarm improved adherence with daily tablet intake of EE/drospirenoneFlex, reducing missed pills. EE/drospirenoneFlex provided effective contraception and a good tolerability profile.
Keywords: contraception, efficacy, pill dispenser, tolerability, drospirenone, compliance
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