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`https://doi.org/10.1234/jphysiol.2023.00001`




A Randomized, Double‑Blind, Placebo‑Controlled Trial of a 12‑Week High‑Dose Oral Testosterone Supplement in Healthy Young Men


Authors:





Dr. Elena M. Kovács, PhD – Department of Endocrinology, University of Copenhagen, Denmark


Prof. Daniel S. Lee, MD, MPH – Division of Clinical Research, Seoul National University Hospital, South Korea


Dr. Priya N. Gupta, MSc – Institute for Translational Medicine, New Delhi, India



Correspondence: Elena M. Kovács (elena.kovacs@cphbio.dk)





Abstract



Background

Oral testosterone formulations have historically suffered from low bioavailability and hepatic side‑effects. Recent advances in liposomal encapsulation promise to enhance gastrointestinal absorption while reducing first‑pass metabolism.




Objectives

To evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of a novel liposome‑encapsulated oral testosterone preparation (LTP‑O) over 12 weeks in healthy adult volunteers.




Methods

A double‑blind, randomized, placebo‑controlled Phase I/IIa study enrolled 60 participants (30 mg LTP‑O vs. placebo). Primary endpoints were incidence of adverse events (AEs), changes in liver enzymes, and PK parameters (Cmax, Tmax, AUC0–∞). Secondary endpoints included testosterone levels, luteinizing hormone (LH), follicle‑stimulating hormone (FSH), lipid profile, and body composition.




Results

No serious AEs were reported. Mild gastrointestinal symptoms occurred in 10 % of the treatment group vs. 4 % of placebo (p > 0.05). Liver enzymes remained within normal limits; mean ALT increased by

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