Evidence map›Paper›PMID 33090208›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2021

Dimethandrolone Undecanoate, a Novel, Nonaromatizable Androgen, Increases P1NP in Healthy Men Over 28 Days.

Arthi Thirumalai, Fiona Yuen, John K Amory, Andrew N Hoofnagle, Ronald S Swerdloff, Peter Y Liu, Jill E Long, Diana L Blithe, Christina Wang, Stephanie T Page

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Novel male contraceptives.Future science OA · 2026
    Review
  2. Review
  3. Review
  4. Review
  5. Testosterone Replacement Therapy in Hypogonadal Men.Endocrinology and metabolism clinics of North America · 2022
    Review
  6. Update on Novel Hormonal and Nonhormonal Male Contraceptive Development.The Journal of clinical endocrinology and metabolism · 2021
    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

10 authors at 3 institutions in 1 country.

Arthi ThirumalaiUniversity of Washington, Seattle, Washington.
Fiona YuenThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, California.
John K AmoryUniversity of Washington, Seattle, Washington.
Andrew N HoofnagleUniversity of Washington, Seattle, Washington.
Ronald S SwerdloffThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, California.
Peter Y LiuThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, California.
Jill E LongEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Diana L BlitheEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Christina WangThe Lundquist Institute at Harbor UCLA Medical Center, Torrance, California.
Stephanie T PageUniversity of Washington, Seattle, Washington.
UCLA Medical Center · USUniversity of Washington · USNational Institutes of Health · US

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
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 HHSN275201300024INICHD NIH HHS HHSN275201300025INIDDK NIH HHS T32 DK007247
6 · The paper itself

Abstract

contextDimethandrolone undecanoate (DMAU) is being developed as a male contraceptive. Daily oral administration of DMAU, a potent androgen that is not aromatized, markedly suppresses serum testosterone (T) and estradiol (E2) in healthy men. E2 deficiency can increase bone resorption in men.

objectiveThis work aimed to assess changes in bone turnover markers with DMAU administration in a 28-day study.

designA randomized, double-blind, placebo-controlled study was conducted.

settingThis study took place at 2 academic medical centers.

participantsHealthy men, age 18 to50 years (n = 81), participated.

interventionMen received 0, 100, 200, or 400 mg of oral DMAU for 28 days. Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and procollagen type I amino-terminal propeptide (P1NP; bone formation marker) were measured on days 1 and 28.

main outcome measuresChanges in bone turnover markers and serum hormones over the treatment period were measured.

resultsOn day 28, median serum T and E2 were markedly suppressed in all treatment groups vs placebo (P < .001 for both). Percentage change (%) in serum P1NP significantly differed across treatment groups (P = .007): Serum P1NP significantly increased in the 200 mg (5%, interquartile range [IQR] -7% to 27%) and 400 mg (22%, IQR -1% to 40%) groups relative to placebo (-8%, IQR -20% to 0%). Change (%) in serum CTX did not differ between groups (P = .09).

conclusionsDMAU administration for 28 days to healthy men leads to marked suppression of serum T and E2, yet increases P1NP, a serum marker of bone formation. Longer-term studies of the potent androgen DMAU are warranted to determine its impact on bone health in men.

Indexed as

AdolescentAdultAlkaline PhosphataseBiomarkersBone RemodelingCollagen Type IContraceptive Agents, MaleDouble-Blind MethodHealthy VolunteersHumansMaleMiddle AgedNandrolonePeptide FragmentsPeptidesPlacebosAlkaline PhosphataseALPL protein, humanBiomarkersCollagen Type Icollagen type I trimeric cross-linked peptideContraceptive Agents, Maledimethandrolone-undecanoateNandrolonePeptide FragmentsPeptidesPlacebosProcollagenprocollagen Type I N-terminal peptideandrogenbone formation marker

Identifiers

PMID33090208
PMCPMC7765650
OpenAlexW3093799796

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.