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PERMALINK
`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 <5 IU/L (non‑significant). PK analysis revealed median Cmax = 1,200 pmol/L at Tmax = 2.3 h, AUC0–∞ = 12,500 pmol·h/L—indicating rapid absorption and moderate systemic exposure. Hormonal assays showed a 15 % rise in free testosterone (p < 0.05) without significant changes in LH or FSH. No adverse events were reported.
Discussion: The data support that a single oral dose of the novel compound delivers therapeutic plasma concentrations with minimal hepatic burden, as evidenced by stable liver enzymes and modest increases in circulating testosterone. These findings justify progression to multiple‑dose safety studies and eventual efficacy trials in hypogonadal men.
Conclusion: This Phase I study confirms acceptable tolerability, rapid pharmacokinetics, and biologically relevant hormonal modulation following a single oral dose of the investigational drug, paving the way for further clinical development.
