Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study
Authors Briggs P, Serrani M, Vogtländer K, Parke S, Grant C
Received 1 March 2016
Accepted for publication 2 June 2016
Published 15 September 2016 Volume 2016:8 Pages 477—487
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Lucy Goodman
Peer reviewer comments 3
Editor who approved publication: Professor Elie Al-Chaer
Paula Briggs,1 Marco Serrani,2 Kai Vogtländer,3 Susanne Parke4
1Sexual and Reproductive Health, Southport and Ormskirk Hospital NHS Trust, Merseyside, UK; 2Global Medical Affairs Women’s HealthCare, Bayer Pharma AG, Berlin, 3Global Integrated Analysis & Life Cycle Management Statistics, Bayer Pharma AG, Wuppertal, 4Global Clinical Development Women’s HealthCare, Bayer Pharma AG, Berlin, Germany
Background: Oral contraceptives are still associated with high discontinuation rates, despite their efficacy. There is a wide choice of oral contraceptives available, and the aim of this study was to assess continuation rates, bleeding profile acceptability, and the satisfaction of women in the first year of using a contraceptive pill containing estradiol valerate and dienogest (E2V/DNG) versus a progestogen-only pill (POP) in a real-life setting after discontinuing an ethinylestradiol-containing pill.
Methods and results: In this prospective, noninterventional, observational study, 3,152 patients were included for the efficacy analyses (n=2,558 women in the E2V/DNG group and n=592 in the POP group (two patients fulfilled the criteria of the efficacy population, but the used product was not known). Women had been taking an ethinylestradiol-containing pill ≥3 months before deciding to switch to the E2V/DNG pill or a POP. Overall, 19.8% (n=506) of E2V/DNG users and 25.8% (n=153) of POP users discontinued their prescribed pill. The median time to discontinuation was 157.0 days and 127.5 days, respectively. Time to discontinuation due to bleeding (P<0.0001) or other reasons (P=0.022) was significantly longer in the E2V/DNG group versus the POP group. The E2V/DNG pill was also associated with shorter (48.7% vs 44.1%), lighter (54% vs 46.1%), and less painful bleeding (91.1% vs 73.7%) and greater user satisfaction (80.7% vs 64.6%) than POP use, within 3–5 months after switch.
Conclusion: The E2V/DNG pill was associated with higher rates of continuation, bleeding profile acceptability, and user satisfaction than POP use and may be an alternative option for women who are dissatisfied with their current pill.
Keywords: contraception, oral contraceptive, compliance, estradiol valerate, dienogest
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