Trial reportThe Journal of clinical endocrinology and metabolism2012
A new combination of testosterone and nestorone transdermal gels for male hormonal contraception.
Trial report in The Journal of clinical endocrinology and metabolism, 2012. 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 49 papers.
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.
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.
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
An Open-Label Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males: Effect of Washing or Clothing Barrier to the Application
Who cites it
49 citing papers in PubMed.
- Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men.The Journal of clinical endocrinology and metabolism · 2020Trial
- Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men.Andrology · 2019Trial
- Validity and Clinically Meaningful Changes in the Psychosexual Daily Questionnaire and Derogatis Interview for Sexual Function Assessment: Results From the Testosterone Trials.The journal of sexual medicine · 2018Trial
- Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial.Contraception · 2014Trial
- Characteristics associated with suppression of spermatogenesis in a male hormonal contraceptive trial using testosterone and Nestorone(®) gels.Andrology · 2013Trial
- Why male contraception still stalls: translational, social, and ethical gaps.Annals of medicine and surgery (2012) · 2026Article
- Review
- From Discovery to Clinical Trial: YCT-529, an Oral NonHormonal Male Contraceptive Targeting the Retinoic Acid Receptor Alpha.Journal of medicinal chemistry · 2026Article
- Progestins - a review of clinical application in gynecology.Annals of medicine · 2025Review
- Evaluation of dimethandrolone undecanoate in non-human primates as a candidate for long-acting injectable male contraceptive.Andrology · 2025Article
- Development of a transdermal gel for reversible male contraception.Contraception · 2025Review
- Male Hormonal Contraception-Current Stage of Knowledge.Journal of clinical medicine · 2025Review
- Hormone Regulation in Testicular Development and Function.International journal of molecular sciences · 2024Review
- Male animal sterilization: history, current practices, and potential methods for replacing castration.Frontiers in veterinary science · 2024Review
- Male contraception: narrative review of ongoing research.Basic and clinical andrology · 2023Review
- Male contraception development: monitoring effective spermatogenesis suppression utilizing a user-controlled sperm concentration test compared with standard semen analysis.Fertility and sterility · 2023Article
- Male contraception is coming: Who do men want to prescribe their birth control?Contraception · 2022Article
- Hormonal Male Contraception: Getting to Market.Frontiers in endocrinology · 2022Article
- Emerging approaches to male contraception.Fertility and sterility · 2021Review
- Update on Novel Hormonal and Nonhormonal Male Contraceptive Development.The Journal of clinical endocrinology and metabolism · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
contextCombinations of testosterone (T) and nestorone (NES; a nonandrogenic progestin) transdermal gels may suppress spermatogenesis and prove appealing to men for contraception.
objectiveThe objective of the study was to determine the effectiveness of T gel alone or combined with NES gel in suppressing spermatogenesis. DESIGN AND
settingThis was a randomized, double-blind, comparator clinical trial conducted at two academic medical centers.
participantsNinety-nine healthy male volunteers participated in the study.
interventionsVolunteers were randomized to one of three treatment groups applying daily transdermal gels (group 1: T gel 10 g+NES 0 mg/placebo gel; group 2: T gel 10 g+NES gel 8 mg; group 3: T gel 10 g+NES gel 12 mg). MAIN OUTCOME VARIABLE: The main outcome variable of the study was the percentage of men whose sperm concentration was suppressed to 1 million/ml or less by 20-24 wk of treatment.
resultsEfficacy data analyses were performed on 56 subjects who adhered to the protocol and completed at least 20 wk of treatment. The percentage of men whose sperm concentration was 1 million/ml or less was significantly higher for T+NES 8 mg (89%, P<0.0001) and T+NES 12 mg (88%, P=0.0002) compared with T+NES 0 mg group (23%). The median serum total and free T concentrations in all groups were maintained within the adult male range throughout the treatment period. Adverse effects were minimal in all groups.
conclusionA combination of daily NES+T gels suppressed sperm concentration to 1 million/ml or less in 88.5% of men, with minimal adverse effects, and may be further studied as a male transdermal hormonal contraceptive.
Indexed as
Identifiers
What OpenQuestion holds
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.