Evidence map›Paper›PMID 31976519›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2020

Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men.

Fiona Yuen, Arthi Thirumalai, Cindy Pham, Ronald S Swerdloff, Bradley D Anawalt, Peter Y Liu, John K Amory, William J Bremner, Clint Dart, Hongsheng Wu and 5 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.3field-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.

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

20 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. The landscape of male contraception A narrative review.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2024
    Review
  8. Article
  9. Hormone Regulation in Testicular Development and Function.International journal of molecular sciences · 2024
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Testosterone Replacement Therapy in Hypogonadal Men.Endocrinology and metabolism clinics of North America · 2022
    Review
  15. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    Article
  16. Article
  17. Emerging approaches to male contraception.Fertility and sterility · 2021
    Review
  18. Update on Novel Hormonal and Nonhormonal Male Contraceptive Development.The Journal of clinical endocrinology and metabolism · 2021
    Review
  19. Male Contraception.The Yale journal of biology and medicine · 2020
    Review
  20. 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

15 authors at 4 institutions in 1 country.

Fiona YuenDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
Arthi ThirumalaiDepartment of Medicine, University of Washington, Seattle, Washington.
Cindy PhamDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
Ronald S SwerdloffDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
Bradley D AnawaltDepartment of Medicine, University of Washington, Seattle, Washington.
Peter Y LiuDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
John K AmoryDepartment of Medicine, University of Washington, Seattle, Washington.
William J BremnerDepartment of Medicine, University of Washington, Seattle, Washington.
Clint DartHealth Decisions, Durham, North Carolina.
Hongsheng WuHealth Decisions, Durham, North Carolina.
Laura HullDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
Diana L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Jill LongContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Christina WangDepartment of Medicine, Division of Endocrinology, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, California.
Stephanie T PageDepartment of Medicine, University of Washington, Seattle, Washington.
UCLA Medical Center · USUniversity of Washington · USHealth Decisions (United States) · USNational Institutes of Health · US

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
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
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
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1 TR001881NHLBI NIH HHS K24 HL138632NICHD NIH HHS F32 HD097932NICHD NIH HHS HHSN275200800044UNIDDK NIH HHS T32 DK007247
6 · The paper itself

Abstract

background11β-methyl-19-nortestosterone (11β-MNT) is a modified testosterone (T) with androgenic and progestational activity. A single oral dose of the prodrug, 11β-MNT dodecylcarbonate (11β-MNTDC), was well tolerated in healthy men.

methodsWe conducted a randomized, double-blind study at 2 academic medical centers. 42 healthy men (18-50 years) were randomized to receive oral placebo or 11β-MNTDC, 200 or 400 mg daily, for 28 consecutive days. Primary outcome (safety and tolerability) measures were assessed twice per week. Subjects underwent serial blood sampling over 24 hours on days 1 and 28 to assess secondary outcomes: pharmacokinetics (serum drug concentrations); pharmacodynamics of 11β-MNTDC (serum sex steroids and gonadotropins); and mood and sexual function (via validated questionnaires).

resultsThere were no serious adverse events. No participants discontinued because of an adverse event or laboratory test abnormality. 11β-MNTDC resulted in a dose-related increase in serum 11β-MNTDC and 11β-MNT concentrations sustained over 24 hours. Administration of 11β-MNTDC resulted in a marked suppression of serum gonadotropins, T, calculated free T, estradiol, and SHBG over the treatment period (P < 0.01). Adverse effects that may be related to 11β-MNTDC included weight gain, acne, headaches, fatigue, and mild mood changes, with 5 men reporting decreased libido and 3 decreased erectile/ejaculatory function. Serum low-density lipoprotein cholesterol, weight (~2 kg), hematocrit, and hemoglobin increased and serum high-density lipoprotein cholesterol decreased in both 11β-MNTDC groups.

conclusionDaily oral 11β-MNTDC for 28 days in healthy men markedly suppressed serum gonadotropin and T concentrations without serious adverse effects. These results warrant further evaluation of 11β-MNTDC as a potential male oral contraceptive.

Indexed as

Administration, OralAdolescentAdultContraceptionContraceptive Agents, MaleDouble-Blind MethodDown-RegulationDrug Administration ScheduleEstrenesGonadotropinsHealthy VolunteersHumansMaleMiddle AgedYoung AdultContraceptive Agents, MaleEstrenesGonadotropinsmethylestrenoloneandrogengonadotropinsmale hormonal contraceptionprogestintestosterone suppression

Identifiers

PMID31976519
PMCPMC7049261
OpenAlexW3000864894

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.