Evidence map›Paper›PMID 30252061›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2019

Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill.

Arthi Thirumalai, Jonas Ceponis, John K Amory, Ronald Swerdloff, Vijaya Surampudi, Peter Y Liu, William J Bremner, Eric Harvey, Diana L Blithe, Min S Lee and 3 more

Abstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
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

32 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Novel male contraceptives.Future science OA · 2026
    Review
  5. Article
  6. [Male contraception-scientific foundations and contemporary progress].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026
    Review
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Willingness to Use Male Contraceptive Pill: Spain-Mozambique Comparison.International journal of environmental research and public health · 2023
    Article
  17. Article
  18. Article
  19. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    Article
  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

13 authors.

Arthi ThirumalaiDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington.
Jonas CeponisLos Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.
John K AmoryDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington.
Ronald SwerdloffLos Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.
Vijaya SurampudiUniversity of California, Los Angeles, Los Angeles, California.
Peter Y LiuLos Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.
William J BremnerDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington.
Eric HarveyHealth Decisions, Durham, North Carolina.
Diana L BlitheNational Institutes of Health - National Institute of Child Health and Human Development, Bethesda, Maryland.
Min S LeeNational Institutes of Health - National Institute of Child Health and Human Development, Bethesda, Maryland.
Laura HullLos Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.
Christina WangLos Angeles Biomedical Research Institute and Harbor UCLA Medical Center, Torrance, California.
Stephanie T PageDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington.

Funding

Diabetes, Obesity and Metabolism Training ProgramT32DK007247 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREGORY J MORTON, KRISTINA Marie UTZSCHNEIDER · 1986 to 2026
$10.0M
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
Retinoic Acid in Male InfertilityK24HD082231 · NICHD · UNIVERSITY OF WASHINGTON · PI AMORY, JOHN K. · 2015 to 2019
$638k
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
NHLBI NIH HHS K24 HL138632NICHD NIH HHS K24 HD082231NIDDK NIH HHS T32 DK007247
6 · The paper itself

Abstract

Context: Dimethandrolone (DMA) has androgenic and progestational activity. Single oral doses of DMA undecanoate (DMAU) were well tolerated and reversibly suppressed serum LH and testosterone (T) in men. Objective: Assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral DMAU. Design: Double-blind, randomized, placebo-controlled study. Setting: Two academic medical centers. Participants: Healthy men (18 to 50 years). Interventions: One hundred men received DMAU [0, 100, 200, or 400 mg, formulated in castor oil/benzyl benzoate (C) or powder (P)] for 28 days. Subjects underwent 24-hour PK sampling on days 1 and 28 and twice weekly ambulatory visits throughout treatment. Main Outcome Measures: Primary outcomes were safety and tolerability parameters (vitals, laboratory data, mood, and sexual function scores) and adverse events. Secondary outcomes were drug PK profiles and PD effects (serum LH, FSH, and sex hormones). Results: Eighty-two subjects completed the study and were included in the analysis. There were no serious adverse events. No clinically significant changes developed in safety laboratory parameters. A significant dose effect was seen for weight, hematocrit, high-density lipoprotein cholesterol, corrected QT interval, and sexual desire. Serum 24-hour average concentrations of DMAU and DMA showed dose-related increases (P < 0.001). All six subjects in the P400 group and 12 of 13 subjects in the C400 group achieved marked suppression of LH and FSH (<1.0 IU/L) and serum T (<50 ng/dL). Conclusions: Daily oral administration of DMAU for 28 days in healthy men is well tolerated. Doses of ≥200 mg markedly suppress serum T, LH, and FSH. These results support further testing of DMAU as a male contraceptive.

Indexed as

Administration, OralAdultContraceptive Agents, MaleDose-Response Relationship, DrugDouble-Blind MethodDrugs, InvestigationalFollicle Stimulating HormoneHealthy VolunteersHumansLuteinizing HormoneMaleNandrolonePlacebosTestosteroneYoung AdultContraceptive Agents, Maledimethandrolone-undecanoateDrugs, InvestigationalFollicle Stimulating HormoneLuteinizing HormoneNandrolonePlacebosTestosterone

Identifiers

PMID30252061
PMCPMC6306388

What OpenQuestion holds

Textmetadata
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.