Evidence map›Paper›PMID 30969032›Full record

Trial reportAndrology2019

Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men.

B D Anawalt, M Y Roth, J Ceponis, V Surampudi, J K Amory, R S Swerdloff, P Y Liu, C Dart, W J Bremner, R Sitruk-Ware and 4 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Andrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
3.2field-weighted citation impact, top 8% 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

25 citing papers in PubMed, 53 citations in OpenAlex.

  1. Novel male contraceptives.Future science OA · 2026
    Review
  2. Article
  3. [Male contraception-scientific foundations and contemporary progress].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022
    Article
  17. Article
  18. Emerging approaches to male contraception.Fertility and sterility · 2021
    Review
  19. Article
  20. Male Contraception.The Yale journal of biology and medicine · 2020
    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

14 authors at 6 institutions in 3 countries.

B D AnawaltDepartment of Medicine, University of Washington, Seattle, WA, USA.ORCID 0000-0003-2652-4032
M Y RothDepartment of Medicine, University of Washington, Seattle, WA, USA.ORCID 0000-0002-3965-9254
J CeponisInstitute of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.ORCID 0000-0003-4261-5014
V SurampudiDepartment of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.ORCID 0000-0002-7105-065X
J K AmoryDepartment of Medicine, University of Washington, Seattle, WA, USA.ORCID 0000-0002-7419-435X
R S SwerdloffDepartment of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.ORCID 0000-0001-6084-6604
P Y LiuDepartment of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.
C DartHealth Decisions, Durham, NC, USA.
W J BremnerDepartment of Medicine, University of Washington, Seattle, WA, USA.ORCID 0000-0002-9769-2554
R Sitruk-WareCenter for Biomedical Research, Population Council, New York, NY, USA.
N KumarCenter for Biomedical Research, Population Council, New York, NY, USA.
D L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.ORCID 0000-0001-5224-9340
S T PageDepartment of Medicine, University of Washington, Seattle, WA, USA.ORCID 0000-0002-6959-6389
C WangDepartment of Medicine, Division of Endocrinology, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Torrance, CA, USA.ORCID 0000-0002-8231-792X
University of Washington · USThe Lundquist Institute · USPopulation Council · USDurham University · GBLithuanian University of Health Sciences · LTNational 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
Spermatogonial Stem Cell Self-Renewal and DifferentiationU54HD042454 · NICHD · UNIVERSITY OF WASHINGTON · PI PAGE, STEPHANIE T · 2002 to 2016
$26.9M
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
UCLA Clinical and Translational Science InstituteKL2TR000122 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$4.5M
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
Intratesticular Sex Steroids and Spermatogenesis in ManK23HD073164 · NICHD · UNIVERSITY OF WASHINGTON · PI ROTH, MARA YVONNE · 2013 to 2015
$390k
NCATS NIH HHS KL2 TR000122NCATS NIH HHS UL1 TR001881NICHD Contraceptive Discovery and Development Branch HHSN275201200002NICHD Contraceptive Discovery and Development Branch HHSN275201300024NICHD NIH HHS HHSN275200403369INICHD NIH HHS HHSN275201200002CNICHD NIH HHS HHSN275201200002INICHD NIH HHS HHSN275201300024INICHD NIH HHS HHSN275201300025INICHD NIH HHS K23 HD073164NICHD NIH HHS U54 HD042454NIDDK NIH HHS T32 DK007571Population CouncilUCLA Clinical and Translational Science Institute at Harbor-UCLA Medical Center
6 · The paper itself

Abstract

backgroundNovel male-based contraceptives are needed to broaden family planning choices. A progestin, Nestorone

objectiveCompare the effectiveness of daily application of a single, combined 8.3 mg Nes-62.5 mg T gel (Nes-T) vs. 62.7 mg T gel to suppress serum FSH and LH concentrations to ≤1.0 IU/L (a threshold associated with suppression of sperm concentrations to ≤1 million and effective contraception) and to compare the pharmacokinetics of serum Nes and T concentrations between the gel groups.

designWe conducted a 28-day, double-blind, controlled trial of 44 healthy men randomized to daily Nes-T or T gel with measurement of hormones at baseline, treatment, and recovery and during 24-h pharmacokinetic studies on days 1 and 28 of treatment.

resultsOf the subjects who met pre-defined inclusion criteria, 84% of the Nes-T group suppressed serum gonadotropin concentrations to ≤1.0 IU/L at days 21-28 vs. 16.7% in the T group (p < 0.001). On day 1, Nes concentrations rose significantly above baseline by 2 h and continued to rise up to 24 h after Nes-T gel application. Nes concentrations were not detectable in the T group. Serum total T concentrations rose and were significantly higher in the T gel group compared to the Nes-T group at 24 h on day 1 and days 11, 14, and 21 (p < 0.01). There were no serious adverse events in either group. About 80% of the subjects reported satisfaction with both gels.

conclusionDaily Nes-T gel effectively and safely suppresses serum gonadotropins and is acceptable to most men. It should be studied further in efficacy trials of hormonal male contraception.

Indexed as

AdolescentAdultContraceptive Agents, HormonalContraceptive Agents, MaleDouble-Blind MethodDrug CombinationsFollicle Stimulating HormoneGonadotropinsHormonal ContraceptionHumansLuteinizing HormoneMaleMiddle AgedNorprogesteronesSpermatogenesisSperm CountContraceptive Agents, HormonalContraceptive Agents, MaleDrug CombinationsFollicle Stimulating HormoneGonadotropinsLuteinizing HormoneNorprogesteronesST 1435TestosteroneTestosterone Congenersgonadotropinsmale hormonal contraceptionnestoroneprogestintestosterone

Identifiers

PMID30969032
PMCPMC6768743
OpenAlexW2938078193

What OpenQuestion 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 OpenQuestion graph.