QuatRx initiates study of andropause treatment

In addition, QuatRx has also started dosing patients in a phase III clinical trial of ospemifene, the company’s product candidate for the treatment of post-menopausal vaginal atrophy, a chronic condition of post-menopausal women.

Andropause is a condition in men caused by a gradual decline in testosterone levels that occurs naturally as men age. Symptoms include muscle wasting, enlarged breasts, urinary tract problems and sexual dysfunction.

The company’s andropause will randomize approximately 100 patients at approximately 20 study sites in the US to receive either 100, 200, or 300 mg fispemifene or placebo for 28 days. Unlike the traditionally andropause treatments, fispemifene is not a formulation of testosterone. Rather, fispemifene utilizes the body’s normal feedback mechanism to increase testosterone levels.

QuatRx’s phase III clinical trial of ospemifene in the treatment of vaginal atrophy will enroll approximately 800 post-menopausal women. Patients will receive 30 or 60 mg of ospemifene or placebo for 12 weeks. Following the treatment phase of the study, patients will be eligible to participate in a one-year extension study.

Ospemifene is a selective estrogen receptor modulator, an orally available small molecule that binds to estrogen receptors and selectively stimulates or blocks estrogen’s activity in different tissue types.