Around 160 men aged 18 to 64 with sexual dysfunction related to secondary hypogonadism, or low levels of testosterone will be included in the randomized, double-blind, placebo-controlled, parallel arm, multi-center trial at about 15 sites in the US.
The Phase II proof-of-concept trial is designed to evaluate the safety and tolerability of oral fispemifene as well as the effects of treatment on the sexual symptoms using patient reported outcome (PRO) endpoints.
Relevant pharmacodynamic and pharmacokinetic parameters will also be assessed to evaluate the ability of fispemifene to endogenously increase the serum testosterone level.
The company expects the trial to run through the end of the year with topline data expected to be reported in the first quarter of 2016.
Apricus Biosciences chief medical officer Barbara Troupin said: "Apricus’ development goals for fispemifene are broader than simply demonstrating an increase in serum levels of testosterone in men with secondary hypogonadism.
"Our overarching objective is to demonstrate additional clinical benefits in symptomatic hypogonadal men, using fispemifene’s novel mechanisms of action, to support approval in the US market.
"The multi-indication development program is designed to explore additional clinical benefits of fispemifene in other urological conditions where there is currently an unmet need."
Male hypogonadism or low testosterone is related with men whose total testosterone is less than 280-300 ng/dL.
Hypogonadism is estimated to affect up to 39% of US men over the age of 45, according to a Hypogonadism in Males (HIM) study.