Evidence map›Paper›PMID 38663539›Full record

Trial reportContraception2024

Emergency contraception for individuals weighing 80 kg or greater: A randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel.

Alison Edelman, Jeffrey T Jensen, Jill Brown, Michael Thomas, David F Archer, Courtney A Schreiber, Stephanie Teal, Carolyn Westhoff, Clint Dart, Diana L Blithe

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Contraception, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03537768 (A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
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.

NCT03537768 phase4terminatednot on this map

A Multi-center, Randomized Study of the Efficacy of Ulipristal Acetate (UPA) 30 mg, Levonorgestrel (LNG) 1.5 mg, and LNG 3.0 mg for Emergency Contraception (EC) in Women With Weight ≥ 80 kg

TypeinterventionalSponsorKimberly MyerRan2018 to 2022Enrolled532ConditionsContraceptionArmsUlipristal Acetate, Levonorgestrel
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. 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 9 institutions in 1 country.

Alison EdelmanDepartment of OB/GYN, Oregon Health & Science University, Portland, OR, United States. Electronic address: edelmana@ohsu.edu.
Jeffrey T JensenDepartment of OB/GYN, Oregon Health & Science University, Portland, OR, United States.
Jill BrownDepartment of OB/GYN, Uniformed Services University of the Health Sciences, Bethesda, MD, United States.
Michael ThomasDepartment of OB/GYN, University of Cincinnati, Cincinnati, OH, United States.
David F ArcherClinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.
Courtney A SchreiberPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
Stephanie TealDepartment of OB/GYN, University Hospitals, Cleveland, OH, United States.
Carolyn WesthoffDepartment of OB/GYN, Columbia University, New York, NY, United States.
Clint DartHealth Decisions, A division of Premier Research, Durham, NC, United States.
Diana L BlitheEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.
Oregon Health & Science University · USColumbia University · USEastern Virginia Medical School · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USHealth Decisions (United States) · USUniformed Services University of the Health Sciences · USUniversity Hospitals of Cleveland · USUniversity of Cincinnati · USUniversity of Pennsylvania · US

Funding

Development of novel contraceptive methods for men and womenZIBHD008987 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI BLITHE, DIANA · 2019 to 2025
$7.2M
NICHD NIH HHS HHSN275201300008I
6 · The paper itself

Abstract

objectivesTo compare the efficacy of emergency contraception (EC) regimens used within 72 hours of unprotected intercourse in individuals weighing ≥80 kg. STUDY

designWe enrolled reproductive-aged healthy women in a multicenter, single-blind, randomized study of levonorgestrel 1.5 mg (LNG1X) and 3.0 mg (LNG2X) and ulipristal acetate 30 mg (UPA) (enrollment goal 1200). Key eligibility requirements included regular cycles, weight >/= 80kg, unprotected intercourse within 72 hours, no recent use of hormonal contraception, a negative urine pregnancy test (UPT), and willingness to abstain from intercourse until next menses. To assess our primary outcome of incidence of pregnancy, participants completed home UPTs; if no menses by 2-weeks post-treatment, or a positive UPT, they returned for an in-person visit with quantitative serum human chorionic gonadotropin and ultrasound.

resultsWe enrolled and randomized 532; 44 were not dosed or not evaluable for primary end point, leaving an analyzable sample of 488 (173 LNG1X, 158 LNG2X, 157 UPA) with similar demographics between groups (mean age 29.6 years [5.74], body mass index 37.09 kg/m

conclusionsAlthough slow enrollment limited our study power, we found no differences in pregnancy rates between EC regimens among women weighing 80 kg or more. Our results are not able to refute or support differences between the treatment arms. CLINICAL

trial registrationClinicalTrials.gov, www.clincialtrials.gov Clinical trials#: NCT03537768. IMPLICATIONS: Women weighing 80 kg or more experienced no differences in pregnancy rates between oral EC regimens but due to several significant study limitations including sample size and the lack of a study population at high risk of pregnancy, our results are not able to determine if differences in treatment effectiveness exist.

Indexed as

Contraception, PostcoitalLevonorgestrelNorpregnadienesAdolescentAdultBody WeightFemaleHumansPregnancyPregnancy RateSingle-Blind MethodYoung AdultLevonorgestrelNorpregnadienesulipristal acetateBMIEmergency contraceptionLevonorgestrelObesityUlipristal acetate

Identifiers

PMID38663539
PMCPMC11297686
OpenAlexW4395053720

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.