Evidence map›Paper›PMID 32298717›Full record

Trial reportContraception2020

Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype.

Brian T Nguyen, Maritza T Farrant, Bradley D Anawalt, Fiona Yuen, Arthi Thirumalai, John K Amory, Ronald S Swerdloff, William J Bremner, Peter Y Liu, Diana L Blithe and 2 more

Open access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contraception, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.5field-weighted citation impact, top 10% 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

8 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    Article
  7. Update on Novel Hormonal and Nonhormonal Male Contraceptive Development.The Journal of clinical endocrinology and metabolism · 2021
    Review
  8. 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

12 authors at 4 institutions in 1 country.

Brian T NguyenDepartment of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA; The Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA. Electronic address: nguyenbt@usc.edu.
Maritza T FarrantDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Bradley D AnawaltDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Fiona YuenThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.
Arthi ThirumalaiDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
John K AmoryDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Ronald S SwerdloffThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.
William J BremnerDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Peter Y LiuThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.
Diana L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, USA.
Stephanie T PageDepartment of Medicine, University of Washington School of Medicine, Seattle, WA, USA.
Christina WangThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, CA, USA.
University of Washington · USUCLA Medical Center · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USUniversity of Southern California · US

Funding

Diabetes, Obesity and Metabolism Training ProgramT32DK007247 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREGORY J MORTON, KRISTINA Marie UTZSCHNEIDER · 1986 to 2026
$10.0M
Mentorship in the Endocrinology of SleepK24HL138632 · NHLBI · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI LIU, PETER YIWEN · 2018 to 2022
$598k
Examining the Androgenic and Progestational Effects of Novel Androgens for Male ContraceptionF32HD097932 · NICHD · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · PI YUEN, FIONA N · 2019 to 2021
$205k
NHLBI NIH HHS K24 HL138632NICHD NIH HHS F32 HD097932NICHD NIH HHS HHSN275201200002INICHD NIH HHS HHSN275201300024INICHD NIH HHS HHSN275201300025INIDDK NIH HHS T32 DK007247
6 · The paper itself

Abstract

objectiveTo determine men's satisfaction with and acceptability of a once-daily, oral regimen of dimethandrolone undecanoate (DMAU) versus placebo when used for 28 days. STUDY

designAfter a Phase I double-blind, randomized, placebo-controlled, dose-escalating trial of oral DMAU for 28-days, 57 healthy male volunteers completed a survey assessing their experience and satisfaction with the regimen. In the trial, participants were randomized to receive up to 4 DMAU capsules daily versus placebo and instructed to ingest them within 30 min of consuming a high fat meal. Pharmacokinetic and pharmacodynamic profiles were performed, followed by a 6-week recovery phase. Participants were counseled that they could not rely on the drug for contraception.

resultsFifty-seven participants were offered acceptability surveys (39 DMAU, 18 placebo). Most respondents, 80% (45/56), reported satisfaction with the method; 77% (44/57) would recommend it. 54% (31/57), reported that, if available, they would use the method as their primary contraceptive. More respondents reported satisfaction with active DMAU than placebo (87% vs. 67%; p = 0.05). Most respondents, 91% (52/57), reported no difficulty with having to take up to 4 pills within 30 min of ingesting a high-fat meal.

conclusionMost participants reported that the study method, daily oral DMAU or placebo, was satisfactory and acceptable. Having to take the drug after a high-fat meal did not detract from acceptability. IMPLICATIONS: Most participants in a 4-week trial of daily DMAU capsules would recommend and use the method. High satisfaction among DMAU and placebo groups affirms acceptability of a daily male contraceptive pill, warranting further study of oral DMAU.

Indexed as

Contraceptive Agents, MaleContraceptionDouble-Blind MethodHumansMaleNandrolone7alpha,11beta-dimethyl-19-nortestosteroneContraceptive Agents, MaleNandroloneAcceptabilityAndrogen-Progestin ActionsDimethandrolone undecanoateHormonal male contraceptionMale contraception

Identifiers

PMID32298717
PMCPMC7287214
OpenAlexW3016316104

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.