looks promising with ED, ED endpoints met - not sure they can prove libido, since estrogen is required for libido, perhaps Fis. works better than clomid and Endroxal.
QuatRx Pharmaceuticals Reports Positive Results From A Phase 2 Trial Of Fispemifene
ANN ARBOR, Mich., Jan. 8 /PRNewswire/ -- QuatRx Pharmaceuticals today announced positive results from its Phase 2 clinical study of fispemifene in men with low testosterone levels. Fispemifene is a new, 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.
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 a 60%, 60% and 78% increase in testosterone levels, respectively, compared to baseline, while patients treated with placebo showed a 14% increase in testosterone levels (p<0.05, p<0.01, p<0.001 (fispemifene vs. placebo), respectively). Actual increases in total testosterone ranged from 28.3 ng/dL for placebo to 196.5 ng/dL for 300 mg fispemifene. In all dose-groups the mean testosterone level increased into the normal range of 300 ng/dL to 900 ng/dL. All primary endpoints defined by the study protocol were met and no safety issues were observed. |
