Estetrol‐Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia

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 ag...

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Published in:BJOG : an international journal of obstetrics and gynaecology Vol. 129; no. 1; pp. 63 - 71
Main Authors: Gemzell‐Danielsson, K, Apter, D, Zatik, J, Weyers, S, Piltonen, T, Suturina, L, Apolikhina, I, Jost, M, Creinin, MD, Foidart, J‐M
Format: Journal Article
Language:English
Published: England Wiley Subscription Services, Inc 01.01.2022
John Wiley and Sons Inc
Subjects:
Acne
Adolescent
Adult
Adverse events
Birth control
Bleeding
Bleeding pattern
Body mass index
combined oral contraception
Contraception
contraceptive efficacy
Contraceptives, Oral, Combined - administration & dosage
Contraceptives, Oral, Combined - adverse effects
drospirenone
Effectiveness
estetrol
Estetrol - administration & dosage
Estetrol - adverse effects
Europe
Female
Hemorrhage
Humans
Menstruation
Metrorrhagia
Middle Aged
native estrogen
Oral contraceptives
Patient safety
Russia
Safety
Sexual intercourse
Thromboembolism
Vagina
Womens health
Young Adult
Europe
Russia
combined oral contraception
estetrol
contraceptive efficacy
safety
native estrogen
drospirenone
Bleeding pattern
ISSN:1470-0328, 1471-0528, 1471-0528
Online Access:Get full text
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Summary: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. Conclusion E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile. Tweetable A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. Tweetable A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. This article includes Author Insights, a video available at: https://vimeo.com/bjog/authorinsights16840
Bibliography:https://vimeo.com/bjog/authorinsights16840
This article includes Author Insights, a video abstract available at
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SourceType-Scholarly Journals-1
ObjectType-Feature-2
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This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16840
ISSN:1470-0328
1471-0528
1471-0528
DOI:10.1111/1471-0528.16840