Testosterone Solution in Hypogonadal Men (TSAT Study)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Parallel Study with an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men
IRAS ID
126565
Contact name
Frederick Wu
Contact email
Sponsor organisation
Eli Lilly and Company LTD
Eudract number
2012-004866-16
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Sexual dysfunction and lack of energy have been identified as important symptoms commonly reported by men with hypogonadism (Novák et al. 2002; Moncada 2006; Morley et al. 2006; Rosen et al. 2009). Testosterone Solution is indicated for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
A previous study demonstrated that after being treated with Testosterone Solution, the majority of participants achieved total testosterone level within the normal range by Day 15. However, the study lacked a placebo arm and a reliable patient-reported outcome instrument (eg. questionnaire) to assess improvement.
In the proposed TSAT Study, 2 newly developed patient-reported outcome instruments (questionnaires) will be utilised to capture the impact of Testosterone Solution vs. placebo on 1) the level of sexual arousal, interest, and drive, and 2) energy.
To be eligible for enrolment for this study, participants have to be at least 18 years of age, have low levels of testosterone and be experiencing decreased energy levels and/or decreased sexual drive.
Testosterone Solution is provided in a metered dose pump which delivers 30 mg (1.5 ml) of Testosterone Solution with each pump actuation. Testosterone Solution is topically applied to the underarm.
The study is divided into two parts:
DOUBLE-BLIND phase - participants will be randomly assigned into Testosterone Solution arm or a placebo arm. This phase will include a screening period (lasting 4 weeks, involving 2 visits) and a treatment period (lasting 12 weeks, involving 6 visits).
OPEN-LABEL EXTENSION phase - participants who complete the double-blind phase of the study, and who still meet eligibility criteria for the study, will have the option to enrol in open-label extension phase (lasting 24 weeks, involving 9 visits).Study assessments will include: physical examinations (including 3 digital rectal examinations), blood and urine tests, and questionnaires.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0256
Date of REC Opinion
13 Jun 2013
REC opinion
Further Information Favourable Opinion