Ausio header

 

Clinical Studies

RANDOMIZED, DOUBLE-BLIND, SINGLE RISING-DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERS

photoAn initial single rising-dose Phase 1 clinical trial was conducted in healthy male and female volunteers to evaluate the safety and pharmacokinetics of AUS-131. AUS-131 was well tolerated at all doses tested and exhibited favorable pharmacokinetics suitable for twice-daily dosing. Study results have been published in the February 2011 issue of Menopause.

RANDOMIZED, DOUBLE-BLIND, RISING MULTIPLE DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERS

A 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.

ONGOING STUDIES

A Phase 2a “proof-of-concept” 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 “proof-of-concept” study examining the effects of AUS-131 in men with benign prostatic hyperplasia (BPH) is ongoing. This study is a multicenter, double-blind, randomized, placebo-controlled dose-response study, with clinical sites in the United States, Australia and India. The VMS study has recently been successfully completed (169 patients) and the BPH study is scheduled for completion in 2015.

 

 
   

Home Contact UsDirections