Trial reportJournal of andrology
Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation.
Trial report in Journal of andrology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Testosterone Therapy With Subcutaneous Injections: A Safe, Practical, and Reasonable Option.The Journal of clinical endocrinology and metabolism · 2022Pooled it
- Curcumin enhances the oral bioavailability of testosterone by inhibiting its intestinal metabolism.Drug metabolism and disposition: the biological fate of chemicals · 2025Trial
- Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11β-MNTDC in healthy men.Andrology · 2021Trial
- A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.The Journal of clinical endocrinology and metabolism · 2020Trial
- Daily Oral Administration of the Novel Androgen 11β-MNTDC Markedly Suppresses Serum Gonadotropins in Healthy Men.The Journal of clinical endocrinology and metabolism · 2020Trial
- Safety and Pharmacokinetics of Single-Dose Novel Oral Androgen 11β-Methyl-19-Nortestosterone-17β-Dodecylcarbonate in Men.The Journal of clinical endocrinology and metabolism · 2019Trial
- Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill.The Journal of clinical endocrinology and metabolism · 2019Trial
- Trial
- Trial
- Dietary fat modulates the testosterone pharmacokinetics of a new self-emulsifying formulation of oral testosterone undecanoate in hypogonadal men.Journal of andrologyTrial
- Treatment of Symptomatic Male Hypogonadism with New Oral Testosterone Therapies: A Comparative Review of Jatenzo, Tlando, and Kyzatrex.Medicines (Basel, Switzerland) · 2025Review
- Patient Satisfaction with Oral Testosterone Undecanoate in Men Who Received Prior Testosterone Therapy: An Open-Label, Single-Center Clinical Trial.The world journal of men's health · 2024Article
- Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights.Drug, healthcare and patient safety · 2023Review
- JATENZO®: Challenges in the development of oral testosterone.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
- An oral lipidic native testosterone formulation that is absorbed independent of food.European journal of endocrinology · 2021Article
- Type 1 Nuclear Receptor Activity in Breast Cancer: Translating Preclinical Insights to the Clinic.Cancers · 2021Review
- Continuing the search for a hormonal male contraceptive.Best practice & research. Clinical obstetrics & gynaecology · 2020Review
- Accurate measurement of androgen after androgen esters: problems created by ex vivo esterase effects and LC-MS/MS interference.Andrology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
Many hypogonadal men prefer oral testosterone (T) treatment. Oral T undecanoate (TU) is available in many countries, but not in the United States. We aimed to assess the pharmacokinetics of oral TU in a new self-emulsifying drug delivery system formulation. Pharmacokinetics studies were conducted in 3 parts: 12 hypogonadal men were enrolled in 2 centers for a 1-day dosing study; 29 participants were enrolled from 3 centers for a 7-day dosing study; and 15 participants were enrolled from 1 center for a 28-day dosing study. Serial blood samples for serum sex hormone measurements by liquid chromatography-tandem mass spectrometry were drawn for up to 36 hours after oral TU administration. Mean serum T levels (C(avg)) after oral dosing of T 200 mg as TU twice daily with food were within the adult male range in most participants in the 1-, 7-, and 28-day dosing studies but were much lower in the fasting state. The dose-proportional increase in C(avg) of serum T after oral T 300 mg twice daily resulted in more participants with supraphysiologic serum T levels. In the 28-day study, trough serum T reached a steady state at day 7. Serum dihydrotestosterone and estradiol levels tracked serum T concentration. Dihydrotestosterone-testosterone ratios increased 3-fold after oral TU administration. Oral T 200 mg twice daily as TU in a new SEDDS formulation may be a viable therapy for hypogonadal men.
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