Clarus Therapeutics, a men's health specialty pharmaceutical company, has started dosing patients in a Phase lll clinical trial (inTUne) of jatenzo to treat hypogonadism in males.
Currently under development, jatenzo is an oral testosterone replacement therapy and a T prodrug that is expected treat men diagnosed with testosterone deficiency together with an associated medical condition, also known as hypogonadism.
Clarus noted that inTUne is a multicentre, randomised, open-label, trial designed to evaluate the efficacy and safety of jatenzo in adult hypogonadal male subjects.
During the trail, an active comparator group will receive axiron, a topical testosterone formulation.
Around 180 subjects will be randomly assigned to receive open-label treatment in a 3:1 ratio of oral jatenzo to Axiron.
The primary efficacy time point for assessment of average T concentrations occurs on day 105 of the trial.
Clarus Therapeutics president and CEO Dr Robert Dudley said: "After productive dialogue with the FDA regarding the complete response letter issued for our jatenzo NDA, we launched the inTUne Trial, our third Phase lll trial.
"In our first two Phase lll trials of jatenzo, we successfully demonstrated efficacy and safety consistent with approved T-replacement products. We believe this additional trial will provide the supplemental data requested by the FDA and lead to approval of our NDA.
"There continues to be solid market demand for testosterone replacement products and physicians and their patients strongly favour a new oral alternative to currently approved options. Research has shown that current T-therapies have poor compliance and that men with low-T would prefer an oral alternative.
"We believe jatenzo has the potential to safely and effectively expand treatment options for men who need T-replacement therapy."