Evidence map›Paper›PMID 32550535›Full record

ArticleContraception: X2020

A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen.

Thomas Kimble, Anne E Burke, Kurt T Barnhart, David F Archer, Enrico Colli, Carolyn L Westhoff

Open access · goldAbstract read
In one paragraph

Article in Contraception: X, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.

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  13. Contraceptive Care in the Rheumatic Diseases: A Review.Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2024
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  19. New Contraception Update - Annovera, Phexxi, Slynd, and Twirla.Current obstetrics and gynecology reports · 2022
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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

6 authors at 5 institutions in 2 countries.

Thomas KimbleEastern Virginia Medical School, Norfolk, VA, USA.
Anne E BurkeDepartment of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Kurt T BarnhartPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
David F ArcherEastern Virginia Medical School, Norfolk, VA, USA.
Enrico ColliExeltis, Madrid, Spain.
Carolyn L WesthoffDepartment of Obstetrics and Gynecology, and Mailman School of Public Health, Columbia University, New York, NY, USA.
Eastern Virginia Medical School · USColumbia University · USJohns Hopkins Medicine · USUnidades Centrales Científico-Técnicas · ESUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate contraceptive effectiveness and safety of oral drospirenone 4 mg 24/4-day regimen in the United States. STUDY

designWe performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles in nonbreastfeeding women aged ≤ 35 years. We assessed adverse events (AEs), including hyperkalemia and venous thromboembolism.

resultsOf 1006 women who received at least one dose of drospirenone, 352 women (35.0%) completed the trial and 654 (65.0%) women discontinued before trial end. Most participants (92.2%) were ≤ 35 years; one third had a body mass index (BMI) ≥ 30 kg/m

conclusionDrospirenone 4 mg 24/4 regimen provides effective contraception with a good safety/tolerability profile in a broad group of women, including overweight or obese women. IMPLICATIONS: This new progestin-only contraceptive, drospirenone 4 mg in a 24/4 regimen, provides a contraceptive option for the majority of women regardless of blood pressure or BMI.

Indexed as

24/4-day regimenEfficacyProgesterone/progestin-only pillSafetyScheduled bleeding

Identifiers

PMID32550535
PMCPMC7286157
OpenAlexW3003625375

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.