CLAR-09007 ORAL TESTOSTERONE UNDECANOATE IN HYPOGONADAL MEN
Research type
Research Study
Full title
PHASE III, ACTIVE-CONTROLLED, SAFETY AND EFFICACY TRIAL OF ORAL TESTOSTERONE UNDECANOATE (TU) IN HYPOGONADAL MEN
IRAS ID
75870
Contact name
Thomas Hugh Jones
Sponsor organisation
Clarus Therapeutics Inc.
Eudract number
2011-001638-41
Clinicaltrials.gov Identifier
Research summary
A new oral self-emulsifying drug delivery system (SEDDS) containing a testosterone (T) prodrug has been designed by Clarus Therapeutics for potential use as testosterone replacement therapy in hypogonadal men. This unique oral prodrug formulation consists of testosterone undecanoate (TU) in a lipid matrix designed to favor the absorption of T via the intestinal lymphatics thereby resulting in less first-pass metabolism. The androgenic activity of oral TU occurs when the the TU undergoes an enzimatic reaction in plasma and tissue to liberate free T. Following on the results of two Phase II studies with the same formulation - 24 and 15 subjects treated twice-daily with 200 mg of Testosterone (T) as Testosterone Undecanoate (TU) for 7 and 28 days respectively and a study to determine the effect of food with various levels of fat on the pharmacokinetics of Clarus??s TU formulation which indicated that the formulation can be taken with meals across the spectrum of low-normal-high fat, but should not be taken on an empty stomach, the primary objective of this study is to determine the safety and efficacy of oral TU in hypogonadal men for androgen replacement therapy during approximately one year of continuous therapy. Efficacy will be assessed on the basis of serum T concentrations days after final dose titration. 300 subjects will be randomized to receive either oral TU ?? (Group A - N=150) or an approved 1% transdermal T-gel (i.e., AndroGel©, Group B - N=150) Doses will be titrated, if needed, based upon the serum T sampling obtained after the first 4 weeks of treatment (i.e., at steady-state). A second titration will be scheduled, if needed, after 2 weeks of treatment at the titrated dose. Subjects will be treated and followed for 12 months.Clarus Therapeutics designed oral formulation aim to be a valid alternative as replacement therapy to the only oral T formulation currently on the market and to the other T formulations which involve different routes of administration such as buccal, intramuscular, implants and transdermal preparations (patches).
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/NW/0640
Date of REC Opinion
1 Nov 2011
REC opinion
Further Information Favourable Opinion