Estetrol-drospirenone combination oral contraceptive : a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia
Gemzell-Danielsson, K.; Apter, D.; Zatik, J.; Weyers, S.; Piltonen, T.; Suturina, L.; Apolikhina, I; Jost, M.; Creinin, MD.; Foidart, J-M. (2022-01-07)
Gemzell-Danielsson, K, Apter, D, Zatik, J, Weyers, S, Piltonen, T, Suturina, L, Apolikhina, I, Jost, M, Creinin, MD, Foidart, J-M. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG 2022; https://doi.org/10.1111/1471-0528.16840. 129: 63– 71
© 2021 Estetra SRL. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
https://creativecommons.org/licenses/by-nc-nd/4.0/
https://urn.fi/URN:NBN:fi-fe2022030922683
Tiivistelmä
Abstract
Objectives: To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.
Design: Multicenter, open-label, phase 3 trial.
Setting: Sixty-nine sites in Europe and Russia.
Population: Sexually active women aged 18–50 years with regular menstrual cycles and body mass index ≤35 kg/m².
Methods: E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary.
Main outcome measures: Pearl Index (PI) for women 18–35 years (overall and method-failure), bleeding pattern and AEs.
Results: A total of 1553 women aged 18–50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15–1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06–0.83). Scheduled bleeding/spotting occurred in 91.9–94.4% of women over Cycles 1 to 12 and lasted a median of 4–5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events.
Conclusions: E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile.
Tweetable abstract: A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile.
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