Evidence map›Paper›PMID 22055339›Full record

Trial reportAmerican journal of obstetrics and gynecology2012

Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial.

Tessa Madden, Sarah Proehl, Jenifer E Allsworth, Gina M Secura, Jeffrey F Peipert

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

Trial report in American journal of obstetrics and gynecology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986439 (The Contraceptive Choice Project), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 8% 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.

NCT01986439 unknown statusnot on this map

The Contraceptive Choice Project

TypeobservationalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2007 to 2016Enrolled9,256ConditionsUnintended Pregnancy, Teen Births, Abortion, Contraception
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Hormonal Profiles of Menstrual Bleeding Patterns During the Luteal-Follicular Transition.The Journal of clinical endocrinology and metabolism · 2020
    Article
  8. Review
  9. Article
  10. Iatrogenic unscheduled (breakthrough) endometrial bleeding.Reviews in endocrine & metabolic disorders · 2012
    Review
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

5 authors at 1 institution in 1 country.

Tessa MaddenDivision of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
Sarah Proehl
Jenifer E Allsworth
Gina M Secura
Jeffrey F Peipert
Washington University in St. Louis · US

Funding

Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Washington University Institute of Clinical and Translational SciencesKL2TR000450 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$8.8M
Washington University Institute of Clinical and Translational Sciences (KL2)KL2RR024994 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$8.6M
INTERDISCIPLINARY RESEARCH CAREERS IN WOMEN'S HEALTHK12HD001459 · NICHD · WASHINGTON UNIVERSITY · PI SEMENKOVICH, CLAY F. · 2000 to 2014
$6.9M
SHORT-TERM TRAINING STUDENTS IN HEALTH PROFESSIONAL SCHOT35HL007815 · NHLBI · WASHINGTON UNIVERSITY · PI CHUNG, KOONG-NAH · 1995 to 2020
$2.8M
MIDCAREER INVESTIGATOR AWARD IN WOMEN'S HEALTH RESEARCHK24HD001298 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI PEIPERT, JEFFREY FRANK · 2000 to 2009
$1.1M
NCATS NIH HHS KL2 TR000450NCATS NIH HHS UL1 TR000448NCRR NIH HHS KL2 RR024994NCRR NIH HHS KL2RR024994NHLBI NIH HHS 5T35HL007815-15NHLBI NIH HHS T35 HL007815NICHD NIH HHS K12 HD001459NICHD NIH HHS K12HD001459NICHD NIH HHS K24 HD001298NICHD NIH HHS K24 HD01298
6 · The paper itself

Abstract

objectiveThe purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system. STUDY

designWe conducted a randomized controlled trial of naproxen, estradiol, or placebo that was administered over the first 12 weeks of levonorgestrel-releasing intrauterine system use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis.

resultsThere were 129 women who were assigned randomly to naproxen (n = 42 women), estradiol (n = 44 women), or placebo (n = 43 women). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared with placebo (42.9% vs 16.3%; P = .03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (adjusted relative risk, 0.90; 95% confidence interval, 0.84-0.97) compared with placebo. More frequent bleeding and spotting was observed in the estradiol group (adjusted relative risk, 1.25; 95% confidence interval, 1.17-1.34).

conclusionThe administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalEstradiolEstrogensFemaleHumansIntrauterine Devices, MedicatedLevonorgestrelMetrorrhagiaNaproxenTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalEstradiolEstrogensLevonorgestrelNaproxen

Identifiers

PMID22055339
PMCPMC3268863
OpenAlexW1998643963

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.