QUATRX RELEASES DATA FROM STUDY IN TESTOSTERONE DEFICIENCY

QuatRx Pharmaceuticals has announced positive results from its Phase II clinical study of fispemifene in men with low testosterone levels. Fispemifene is a selective estrogen receptor antagonist that is being developed as an oral treatment for testosterone deficiency and associated disorders in men.

Symptoms of low testosterone include sexual dysfunction, muscle wasting, reduced bone density, lowered energy levels and glucose intolerance. Unlike current exogenous testosterone treatments, fispemifene is administered orally once daily and is designed to use the body's natural mechanism to increase and maintain testosterone levels within the body's normal physiologic range, according to the company.

In the randomized, double-blind, placebo-controlled study conducted at 23 sites in the United States, 77 men with secondary hypogonadism were evaluated after four weeks of treatment. Patient groups treated with 100-, 200- and 300-mg doses of fispemifene showed 60, 60 and 78 percent increases in testosterone levels, respectively, compared with baseline, while patients treated with placebo showed a 14 percent increase in testosterone levels. In all dosage groups the mean testosterone level increased into the normal range of 300 to 900 nanograms/dL. All primary endpoints defined by the study protocol were met and no safety issues were observed.