ArticleSexual medicine2015
Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study.
Article in Sexual medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02927210 (Injectable DMAU for Male Contraception), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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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
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- Testosterone Therapy With Subcutaneous Injections: A Safe, Practical, and Reasonable Option.The Journal of clinical endocrinology and metabolism · 2022Pooled it
- Review
- Effect of Testosterone Therapy on Cytochrome P450 3A and P-Glycoprotein Activities Using Midazolam and Digoxin as Probe Substrates Among Transgender Adults.Pharmacotherapy · 2026Article
- A Star-PEGylation Strategy to Improve Testosterone Pharmacokinetics.Molecules (Basel, Switzerland) · 2026Article
- Allometric Scaling of Testosterone Enanthate Pharmacokinetics to Adolescent Hypogonadal Males (IM and SC Administration).Journal of the Endocrine Society · 2023Article
- Misadventures in Toxicology: Concentration Matters for Testosterone-Induced Neurotoxicity.Toxics · 2023Article
- Review
- Testosterone therapy in children and adolescents: to whom, how, when?International journal of impotence research · 2022Review
- Testosterone Replacement Therapy in Hypogonadal Men.Endocrinology and metabolism clinics of North America · 2022Review
- Pharmacokinetics of testosterone therapies in relation to diurnal variation of serum testosterone levels as men age.Andrology · 2022Review
- Subcutaneous Testosterone Is Effective and Safe as Gender-Affirming Hormone Therapy in Transmasculine and Gender-Diverse Adolescents and Young Adults: A Single Center's 8-Year Experience.Transgender health · 2021Article
- Late-onset hypogonadism: Clinical evidence, biological aspects and evolutionary considerations.Ageing research reviews · 2021Review
- Testosterone Use in Adolescent Males: Current Practice and Unmet Needs.Journal of the Endocrine Society · 2021Review
- Pharmacokinetics and Acceptability of Subcutaneous Injection of Testosterone Undecanoate.Journal of the Endocrine Society · 2019Article
- Serum Testosterone Concentrations Remain Stable Between Injections in Patients Receiving Subcutaneous Testosterone.Journal of the Endocrine Society · 2017Article
- Localized Rhabdomyolysis Associated With Testosterone Enanthate for Gender-Affirming Hormonal Therapy.AACE clinical case reportsArticle
- Efficacy of Fixed Low-Dose Weekly Subcutaneous Testosterone Self-Administration in Transgender Male Patients in India.Indian journal of endocrinology and metabolismArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHypogonadism is one of the most common male endocrine problems. Although many treatments are currently available, unmet need exists for new testosterone (T) replacement therapies that are simple to administer and use, are safe, and mimic physiologic T levels.
aimThe study aim was to determine the pharmacokinetics (PK), safety, and tolerability of T enanthate (TE) administered via a novel single-use autoinjector system, which was designed to eject high-viscosity solutions from a prefilled syringe fitted with a five-eighths-inch 27-gauge needle.
methodsThirty-nine men with hypogonadism entered this dose-finding, open-label, parallel-group study. Patients were washed out of their topical T regimens and randomized to receive 50 or 100 mg of subcutaneous (SC) TE weekly. The reference group were patients with hypogonadism who were maintained on standard 200-mg intramuscular (IM) TE.
main outcome measureThe primary outcome measure was the PK profile of SC TE, analyzed in reference to T levels used by the Food and Drug Administration to approve T products. Secondary outcome measures were safety and tolerability assessments.
resultsBoth doses of SC TE achieved normal average concentrations of serum T within a 168-h dosing interval after injection. Concentration ranges were similar at all time points following 50-mg SC TE injections and following the third injection in the 100-mg arm. Mean steady-state T concentration at week 6 was 422.4 and 895.5 ng/dL for the 50- and 100-mg SC TE arms, respectively. SC TE demonstrated PK dose proportionality. SC TE restored normal serum T with low variation relative to 200-mg IM without clinically significant adverse events.
conclusionsAdministration of TE via this novel injection system restored T levels to normal range in men with hypogonadism. SC TE dosed weekly demonstrated steady, dose-proportional measures of exposure and was well-tolerated. Kaminetsky J, Jaffe JS, Swerdloff RS. Pharmacokinetic profile of subcutaneous testosterone enanthate delivered via a novel, prefilled single-use autoinjector: A phase II study. Sex Med 2015;3:263-273.
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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.