Evidence map›Paper›PMID 33908182›Full record

Trial reportAndrology2021

Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11β-MNTDC in healthy men.

Fiona Yuen, Arthi Thirumalai, Frances A Fernando, Ronald S Swerdloff, Peter Y Liu, Youngju Pak, Laura Hull, Rachelle Bross, Diana L Blithe, Jill E Long and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Andrology, 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
1.0field-weighted citation impact, top 23% 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, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. The landscape of male contraception A narrative review.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Review
  5. Review
  6. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    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

12 authors at 3 institutions in 1 country.

Fiona YuenDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.ORCID 0000-0002-8200-2311
Arthi ThirumalaiDepartment of Medicine, University of Washington, Seattle, WA, USA.
Frances A FernandoContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Ronald S SwerdloffDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.ORCID 0000-0001-6084-6604
Peter Y LiuDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Youngju PakDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Laura HullDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Rachelle BrossDepartment of Medicine, Division of Endocrinology, The 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, National Institutes of Health, Bethesda, MD, USA.
Jill E LongContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
Stephanie T PageDepartment of Medicine, University of Washington, Seattle, WA, USA.
Christina WangDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
UCLA Medical Center · USNational Institutes of Health · USUniversity of Washington · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development HHSN27500005Eunice Kennedy Shriver National Institute of Child Health and Human Development HHSN27500006Eunice Kennedy Shriver National Institute of Child Health and Human Development HHSN2752012002Eunice Kennedy Shriver National Institute of Child Health and Human Development HHSN27520130024INCATS NIH HHS UL1TR0001881NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1TR000423NCATS NIH HHS UL1 TR001881NHLBI NIH HHS K24 HL138632NICHD NIH HHS F32 HD097932NICHD NIH HHS HHSN275201300025IRobert McMillen Professorship in Lipid Research
6 · The paper itself

Abstract

backgroundDimethandrolone (DMA) and 11β-methyl-19-nortestosterone (11β-MNT) are two novel compounds with both androgenic and progestational activity that are under investigation as potential male hormonal contraceptives. Their metabolic effects have never been compared in men.

objectiveAssess for changes in insulin sensitivity and adiponectin and compare the metabolic effects of these two novel androgens. MATERIALS/

methodsIn two clinical trials of DMA undecanoate (DMAU) and 11β-MNT dodecylcarbonate (11β-MNTDC), oral prodrugs of DMA and 11β-MNT, healthy men received drug, or placebo for 28 days. Insulin and adiponectin assays were performed on stored samples. Mixed model analyses were performed to compare the effects of the two drugs. Student's t test, or the non-parametric Kruskal-Wallis test as appropriate, was used to evaluate for an effect of active drug versus placebo.

resultsClass effects were seen, with decrease in HDL-C and SHBG, and increase in weight and hematocrit, with no statistically significant differences between the two compounds. No changes in fasting glucose, fasting insulin, or HOMA-IR were seen with either compound. There was a slight decrease in adiponectin with DMAU that was not seen with 11β-MNTDC. An increase in LDL-C was seen with 11β-MNTDC but not with DMAU. DISCUSSION: There were no significant changes in insulin resistance after 28 days of oral administration of these novel androgens despite a mild increase in weight. There may be subtle differences in their metabolic impacts that should be explored in future studies.

conclusionChanges in metabolic parameters should be carefully monitored when investigating androgenic compounds.

Indexed as

AdiponectinAdministration, OralAdultAndrogensBlood GlucoseCholesterol, HDLCholesterol, LDLContraceptive Agents, MaleFastingHealthy VolunteersHematocritHumansInsulinInsulin ResistanceMaleNandrolone11-methyl-19-nortestosterone-17-dodecylcarbonateAdiponectinADIPOQ protein, humanAndrogensBlood GlucoseCholesterol, HDLCholesterol, LDLContraceptive Agents, Maledimethandrolone-undecanoateInsulinNandroloneSex Hormone-Binding GlobulinSHBG protein, humanandrogenmale hormonal contraceptionprogestin

Identifiers

PMID33908182
PMCPMC8560544
OpenAlexW3159849668

What Socratic 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 Socratic graph.