Evidence map›Paper›PMID 24981149›Full record

Trial reportContraception2014

Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial.

Mara Y Roth, Grace Shih, Niloufar Ilani, Christina Wang, Stephanie T Page, William J Bremner, Ronald S Swerdloff, Regine Sitruk-Ware, Diana L Blithe, John K Amory

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contraception, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
12.2field-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

28 citing papers in PubMed, 67 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. The uniqueness of on-demand male contraception.Molecular aspects of medicine · 2024
    Review
  7. Article
  8. Review
  9. Article
  10. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    Article
  11. Update on Novel Hormonal and Nonhormonal Male Contraceptive Development.The Journal of clinical endocrinology and metabolism · 2021
    Review
  12. Article
  13. Male Contraception.The Yale journal of biology and medicine · 2020
    Review
  14. Development of Novel Male Contraceptives.Clinical and translational science · 2020
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Male hormonal contraception: hope and promise.The lancet. Diabetes & endocrinology · 2017
    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 4 institutions in 1 country.

Mara Y RothUniversity of Washington, Department of Medicine and Center for Research in Reproduction and Contraception. Electronic address: mylang@u.washington.edu.
Grace ShihUniversity of Washington, Department of Family Medicine.
Niloufar IlaniHarbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
Christina WangHarbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
Stephanie T PageUniversity of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
William J BremnerUniversity of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
Ronald S SwerdloffHarbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Department of Medicine, Torrance, CA.
Regine Sitruk-WareCenter for Biomedical Research, Population Council, New York City, NY.
Diana L BlitheContraceptive Discovery and Development Branch, NICHD, Bethesda, MD.
John K AmoryUniversity of Washington, Department of Medicine and Center for Research in Reproduction and Contraception.
University of Washington · USHarbor–UCLA Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USPopulation Council · US

Funding

UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
Spermatogonial Stem Cell Self-Renewal and DifferentiationU54HD042454 · NICHD · UNIVERSITY OF WASHINGTON · PI PAGE, STEPHANIE T · 2002 to 2016
$26.9M
Men's Reproductive Health Research at the Univ of WashingtonK12HD053984 · NICHD · UNIVERSITY OF WASHINGTON · PI BREMNER, WILLIAM J · 2006 to 2016
$2.9M
ENDOCRINOLOGY, METABOLISM &NUTRITION TRAINING GRANTT32DK007571 · NIDDK · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI SWERDLOFF, RONALD SHERWIN · 1988 to 2013
$2.1M
BDADs for Male ContraceptionU01HD060488 · NICHD · UNIVERSITY OF WASHINGTON · PI AMORY, JOHN K. · 2009 to 2013
$1.4M
Intratesticular Sex Steroids and Spermatogenesis in ManK23HD073164 · NICHD · UNIVERSITY OF WASHINGTON · PI ROTH, MARA YVONNE · 2013 to 2015
$390k
NCATS NIH HHS UL1 TR000124NICHD NIH HHS K12 HD053984NICHD NIH HHS K23 HD073164NICHD NIH HHS U01 HD060488NICHD NIH HHS U54 HD042454NIDDK NIH HHS T32 DK007571
6 · The paper itself

Abstract

objectiveFifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method. STUDY

designAs part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis.

resultsOverall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03).

conclusionsA majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men. IMPLICATIONS: A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy.

Indexed as

Patient Acceptance of Health CareAdministration, CutaneousAdolescentAdultContraceptive Agents, MaleDouble-Blind MethodDrug CombinationsGelsHumansMaleMiddle AgedNorprogesteronesSexually Transmitted DiseasesSurveys and QuestionnairesTestosteroneYoung AdultContraceptive Agents, MaleDrug CombinationsGelsNorprogesteronesST 1435TestosteroneAcceptabilityContraceptionNestoroneSpermatogenesisTestosterone

Identifiers

PMID24981149
PMCPMC4269220
OpenAlexW2106009601

What OpenQuestion holds

Textmetadata
LicenceTDM
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.