Trial reportThe Journal of clinical endocrinology and metabolism2020
A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men.
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. An erratum has been issued. Cited by 36 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
36 citing papers in PubMed, 1 synthesis or guideline pooled it, 84 citations in OpenAlex.
- Effects of Testosterone Replacement Therapy on Metabolic Syndrome in Male Patients-Systematic Review.International journal of molecular sciences · 2024Pooled it
- Safety, efficacy, and pharmacokinetics of oral testosterone undecanoate in males with hypogonadism.Andrology · 2025Trial
- Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11β-MNTDC in healthy men.Andrology · 2021Trial
- Testicular ageing as a central hallmark of male senescence: characteristics, molecular mechanisms and emerging therapeutic strategies.Annals of medicine · 2026Review
- Fragment-Resolved Carbon and Hydrogen Isotope Analysis of Urinary Steroids by Orbitrap Mass Spectrometry.Analytical chemistry · 2026Article
- Endocrine-metabolic crosstalk in erectile dysfunction: mechanistic insights and therapeutic implications.International journal of impotence research · 2026Review
- Preserving spermatogenesis in testosterone deficiency: innovations in replacement and stimulatory therapies.Translational andrology and urology · 2025Review
- Treatment of Symptomatic Male Hypogonadism with New Oral Testosterone Therapies: A Comparative Review of Jatenzo, Tlando, and Kyzatrex.Medicines (Basel, Switzerland) · 2025Review
- Testosterone replacement therapy and spermatogenesis in reproductive age men.Nature reviews. Urology · 2025Review
- The Chronobiology of Hormone Administration: "Doctor, What Time Should I Take My Medication?"Endocrine reviews · 2025Review
- Brain Nuclei in the Regulation of Sexual Behavior, Peripheral Nerves Related to Reproduction, and Their Alterations in Neurodegenerative Diseases: A Brief Review.Brain sciences · 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
- Replacement with sex steroids in hypopituitary men and women: implications for gender differences in morbidities and mortality.Reviews in endocrine & metabolic disorders · 2024Review
- Hormone Regulation in Testicular Development and Function.International journal of molecular sciences · 2024Review
- Management of Male Fertility in Hypogonadal Patients on Testosterone Replacement Therapy.Medicina (Kaunas, Lithuania) · 2024Review
- Prevalence and predictive factors of testosterone-induced erythrocytosis: a retrospective single center study.Frontiers in endocrinology · 2024Observational
- New Horizons: Testosterone or Exercise for Cardiometabolic Health in Older Men.The Journal of clinical endocrinology and metabolism · 2023Article
- Strategies to Increase Testosterone in Men Seeking Fertility.Urology research & practice · 2023Article
- Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights.Drug, healthcare and patient safety · 2023Review
- Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations.TouchREVIEWS in endocrinology · 2022Review
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextA novel formulation of oral testosterone (T) undecanoate (TU) was evaluated in a phase 3 clinical trial.
objectiveDetermine efficacy, short-term safety, and alignment of new oral TU formulation with current US approval standards for T replacement therapy.
designRandomized, active-controlled, open-label study. SETTING AND PATIENTS: Academic and private clinical practice sites; enrolled patients were clinically hypogonadal men 18 to 65 years old.
methodsPatients were randomized 3:1 to oral TU, as prescribed (JATENZO®; n = 166) or a topical T product once daily (Axiron®; n = 56) for 3 to 4 months. Dose titration was based on average T levels (Cavg) calculated from serial pharmacokinetic (PK) samples. T was assayed by liquid chromatography-mass spectrometry/mass spectrometry. Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP).
results87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean ± standard deviation) for the oral TU group was 403 ± 128 ng/dL (~14 ± 4 nmol/L); serum T equivalent, ~489 ± 155 ng/dL (17 ± 5 nmol/L); and topical T, 391 ± 140 ng/dL (~14 ± 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg.
conclusionA new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.
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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.