User satisfaction with Estetrol/Drospirenone combined oral contraception: A prospective observational study
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Pedro Viana Pinto1, Carolina Gomes2, Ana M D Pinho3
1São João University Hospital Centre - Faculdade de Medicina da Universidade do Porto, Portugal; Portuguese Society of Contraception (SPDC), Portugal.
Objectives:
This study evaluated women's overall satisfaction with a combined oral contraceptive containing estetrol 15 mg/drospirenone 3 mg (E4/DRSP) in clinical practice.
Methods:
This prospective, multicentre, six-cycle, non-interventional study included women aged 18-45 years who initiated hormonal contraception (starters) or switched from another hormonal contraceptive (switchers) to E4/DRSP.
Results:
Of 380 women starting E4/DRSP, 201 (52.9%) were switchers and 226 (59.5%) completed the six-cycle follow-up. In women with available follow-up data, satisfaction with E4/DRSP was high at Cycle 6 (starters 76.9% [95% CI 68.3-84.0], switchers 72.0% [95% CI 63.5-79.5]), with no significant differences between groups or over time (p > 0.05). Users reported a stable profile across well-being, mood, sexual life, premenstrual period and skin condition. Starters experienced significant improvements in breast tenderness between Cycles 3 and 6 (p = 0.024). Satisfaction with the cycle pattern improved significantly in both groups between baseline and Cycle 3, and baseline and Cycle 6 (all p < 0.05). Adherence among respondents was significantly higher for switchers (95.8%) than starters (83.3%) at Cycle 6 (p = 0.022), and approximately 80% of respondents intended to continue using E4/DRSP. Sixty-six women (17.4% [95% CI 13.6-21.2]) reported discontinuing E4/DRSP because of adverse events (AEs). The types of AEs most reported were consistent with those described in Phase 3 trials, with no new safety signals reported.
Conclusion:
Among women who completed six cycles of follow-up, E4/DRSP users reported high satisfaction, high intention to continue use, and an AE profile generally consistent with that described in Phase 3 trials.