Evidence map›Paper›PMID 24789057›Full record

Trial reportAndrology2014

Single, escalating dose pharmacokinetics, safety and food effects of a new oral androgen dimethandrolone undecanoate in man: a prototype oral male hormonal contraceptive.

Prasanth Surampudi, Stephanie T Page, Ronald S Swerdloff, Jean Jacques Nya-Ngatchou, Peter Y Liu, John K Amory, Andrew Leung, Laura Hull, Diana L Blithe, Jason Woo and 2 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Andrology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

NCT02754687 phase1completednot on this mapstarted 2016, after this paper: background citation

Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men

TypeinterventionalSponsorPremier ResearchRan2016 to 2017Enrolled12ConditionsHealthy Men, Male ContraceptionArmsPlacebo, 11βmethyl nortestosterone dodecylcarbonate
NCT02927210 phase1completednot on this mapstarted 2017, after this paper: background citation

Injectable DMAU for Male Contraception: Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Single IM or SC DMAU Injection Dose Escalation Study in Healthy Male Volunteers

TypeinterventionalSponsorKimberly MyerRan2017 to 2025Enrolled106ConditionsHealthy Men, Male ContraceptionArmsDimethandrolone Undecanoate, Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Testosterone Replacement Therapy in Hypogonadal Men.Endocrinology and metabolism clinics of North America · 2022
    Review
  10. Article
  11. Emerging approaches to male contraception.Fertility and sterility · 2021
    Review
  12. Continuing the search for a hormonal male contraceptive.Best practice & research. Clinical obstetrics & gynaecology · 2020
    Review
  13. Article
  14. Male hormonal contraception: hope and promise.The lancet. Diabetes & endocrinology · 2017
    Review
  15. Male contraception.Fertility and sterility · 2016
    Review
  16. Pipeline for contraceptive development.Fertility and sterility · 2016
    Review
  17. Beyond the Condom: Frontiers in Male Contraception.Seminars in reproductive medicine · 2016
    Review
  18. Review
  19. 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

12 authors at 3 institutions in 1 country.

Prasanth Surampudi *Division of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Stephanie T Page *Division of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Ronald S SwerdloffDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Jean Jacques Nya-NgatchouDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Peter Y LiuDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
John K AmoryDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Andrew LeungDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Laura HullDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Diana L BlitheDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Jason WooDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
William J BremnerDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
Christina WangDivision of Endocrinology, Department of Medicine, Harbor UCLA Medical center and Los Angeles Biomedical Research Institute, Torrance, CA 90501 (PS, RSS, PYL, AL, LH, CW); Division of Endocrinology, Department of Medicine, University of Washington, Seattle WA 98004 (STP, JJN, JKA, WJB); and Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 20892-7510 (DLB, JW).
The Lundquist Institute · USUniversity of Washington · USNational Institutes of Health · US

Funding

UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
Spermatogonial Stem Cell Self-Renewal and DifferentiationU54HD042454 · NICHD · UNIVERSITY OF WASHINGTON · PI AMORY, JOHN K. · 2002 to 2016
$26.9M
Diabetes, Obesity and Metabolism Training ProgramT32DK007247 · NIDDK · UNIVERSITY OF WASHINGTON · PI GREGORY J MORTON, KRISTINA Marie UTZSCHNEIDER · 1986 to 2026
$10.0M
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
NICHD CONTRACEPTIVE CLINICAL TRIALS NETWORK /MALE CONTRACEPTIVE TRIALS-275003369N01HD003369 · NICHD · HARBOR-UCLA RESEARCH AND EDUCATION INSTI · PI SWERDLOFF, RONALD SHERWIN · 2006 to 2006
–
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1TR000124NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1TR000423NICHD NIH HHS 5K12HD053984NICHD NIH HHS HHSN275200800044UNICHD NIH HHS K12 HD053984NICHD NIH HHS N01 HD003369NICHD NIH HHS U54 HD 04245NICHD NIH HHS U54 HD042454NIDDK NIH HHS 5T32 DK007247-35NIDDK NIH HHS T32 DK007247NIDDK NIH HHS T32 DK007571PHS HHS HHSN275200403370IPHS HHS HHSN275201000080UPHS HHS HHSN275201100033U
6 · The paper itself

Abstract

The novel androgen, dimethandrolone (DMA) has both androgenic and progestational activities, properties that may maximize gonadotropin suppression. We assessed the pharmacokinetics of dimethandrolone undecanoate (DMAU), an orally bioavailable, longer acting ester of DMA, for male contraceptive development. Our objective was to examine the safety and pharmacokinetics of single, escalating doses of DMAU (powder in capsule formulation) administered orally with or without food in healthy men. We conducted a randomized, double-blind Phase 1 study. For each dose of DMAU (25-800 mg), 10 male volunteers received DMAU and two received placebo at two academic medical centres. DMAU was administered both fasting and after a high-fat meal (200-800 mg doses). Serial serum samples were collected over 24 h following each dose. DMAU was well tolerated without significant effects on vital signs, safety laboratory tests or electrocardiograms. When administered while fasting, serum DMA (active compound) was detectable in only 4/10 participants after the 800 mg dose. When administered with a 50% fat meal, serum DMA was detectable in all participants given 200 mg DMAU and showed a dose-incremental increase up to 800 mg, with peak levels 4-8 h after taking the dose. Serum gonadotropins and sex hormone concentrations were significantly suppressed 12 h after DMAU administration with food at doses above 200 mg. This first-in-man study demonstrated that a single, oral dose of DMAU up to 800 mg is safe. A high-fat meal markedly improved DMAU/DMA pharmacokinetics.

Indexed as

Administration, OralAdolescentAdultContraceptive Agents, MaleDietary FatsDouble-Blind MethodFastingFoodGonadotropinsHumansMaleMiddle AgedNandrolone7alpha,11beta-dimethyl-19-nortestosteroneContraceptive Agents, MaleDietary Fatsdimethandrolone-undecanoateGonadotropinsNandroloneandrogenscontraceptionpharmacokineticsprogesterone/progestagens

Identifiers

PMID24789057
PMCPMC4069217
OpenAlexW2114774134

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.