Clinical StudiesRANDOMIZED, DOUBLE-BLIND, SINGLE RISING-DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERS RANDOMIZED, DOUBLE-BLIND, RISING MULTIPLE DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERSA second, multiple-dose, placebo-controlled Phase 1 clinical trial was initiated in December 2008. In this study, healthy males and females were given AUS-131 twice daily at doses ranging from 10 mg (total daily dose of 20 mg) to 160 mg (total daily dose of 320 mg) for 2 weeks. Results demonstrated the safety of AUS-131 and an excellent pharmacokinetic profile at all doses tested. Results of both Phase 1 studies were published in the February 2011 issue of Menopause. phase 2a studiesA Phase 2a study examining the effects of AUS-131 on vasomotor symptoms (VMS) (hot flashes and night sweats) in menopausal women has been completed. The results are available on clinicaltrials.gov. A Phase 2a study examining the effects of AUS-131 in men with benign prostatic hyperplasia (BPH) has been completed. The results are available on clinicaltrials.gov. ongoing studiesTwo Phase 2 studies are ongoing for the treatment of triple negative breast cancer and Alzheimer’s disease. Description of the trials are available on clinicaltrials.gov |
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