Evidence map›Paper›PMID 34245666›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2022

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

K Gemzell-Danielsson, D Apter, J Zatik, S Weyers, T Piltonen, L Suturina, I Apolikhina, M Jost, M D Creinin, J-M Foidart

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
10.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 69 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Estetrol: A New Choice for Contraception.Journal of clinical medicine · 2021
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 10 institutions in 6 countries.

K Gemzell-DanielssonDepartment of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.ORCID https://orcid.org/0000-0001-6516-1444
D ApterVL-Medi Clinical Research Centre, Helsinki, Finland.
J ZatikGynaecological Praxis St Anna, Debrecen, Hungary.
S WeyersDepartment of Obstetrics and Gynaecology, University Hospital, Gent, Belgium.
T PiltonenDepartment of Obstetrics and Gynaecology, PEDEGO Research Unit, Medical Research Center, Oulu University Hospital, University of Oulu, Oulu, Finland.
L SuturinaScientific Centre for Family Health and Human Reproduction Problems, Irkutsk, Russia.
I ApolikhinaKulakov National Medical Research Centre for Obstetrics, Gynaecology, and Perinatology, Moscow, Russia.
M JostEstetra SRL, an affiliate Company of Mithra Pharmaceuticals, Liège, Belgium.
M D CreininDepartment of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA.
J-M FoidartEstetra SRL, an affiliate Company of Mithra Pharmaceuticals, Liège, Belgium.
Ghent University Hospital · BEKarolinska University Hospital · SEMithra Pharmaceuticals (Belgium) · BENational Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov of the Ministry of Healthcare of the Russian Federation · RUOulu University Hospital · FIScientific Center of Family Health Problems and Human Reproduction · RUUniversity of California, Davis · USUniversity of Debrecen · HUUniversity of Liège · BEVL-Medi Oy (Finland) · FI

Funding

Estetra SRL, an affiliate company of Mithra Pharmaceuticals n/a
6 · The paper itself

Abstract

objectivesTo assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.

designMulticenter, open-label, phase 3 trial.

settingSixty-nine sites in Europe and Russia. POPULATION: Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m

methodsE4/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 measuresPearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs.

resultsA 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.

conclusionE4/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.

Indexed as

AdolescentAdultContraceptives, Oral, CombinedEstetrolEuropeFemaleHumansMetrorrhagiaMiddle AgedRussiaYoung AdultContraceptives, Oral, Combineddrospirenone and estetrolEstetrolBleeding patterncombined oral contraceptioncontraceptive efficacydrospirenoneestetrolnative estrogensafety

Identifiers

PMID34245666
PMCPMC9290720
OpenAlexW3182301998

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.