title: 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.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Kinderwunschpraxis am Goetheplatz, Frankfurt, Germany ; MVZ Kinderwunschzentrum Wiesbaden GmbH, Wiesbaden, Germany.
authors.forename: Inka
authors.initials: I
authors.lastname: Wiegratz
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Elliesen
authors.affiliation: Clinica Ostetrica e Ginecologica, University of Cagliari, Cagliari, Italy.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Paoletti
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Walzer
authors.affiliation: Bayer HealthCare Pharmaceuticals, Berlin, Germany.
authors.forename: Bodo
authors.initials: B
authors.lastname: Kirsch
keywords: compliance; contraception; drospirenone; efficacy; pill dispenser; tolerability