Clarus Therapeutics Completes Patient Enrollment in Phase 3 Study of its Proprietary Oral Testosterone Replacement Therapy
NORTHBROOK, Ill – May 1, 2012 -- Clarus Therapeutics, Inc., today announced that patient enrollment has been completed in the Company's pivotal Phase 3 clinical trial of its proprietary oral testosterone (T) replacement product (CLR-610). Primary endpoint of the ongoing study is the percentage of men who achieve normal serum T levels after administration of CLR-610 for 90 days. In addition, safety and tolerability will be assessed.
“Generally men with low T receive treatment in the form of topical T gels, transdermal T-patches and T-injectables,” commented Jed Kaminetsky, M.D., clinical assistant professor of urology at the NYU Langone Medical Center and an investigator in Clarus' Phase 3 study. “Patients in my practice with low T have expressed a great interest in the availability of a new oral T product. I believe this is evidenced by the speed with which this clinical trial completed enrollment. I look forward to continuing my work with the Clarus team as we work to complete clinical testing and advance this new treatment option for patients.”
Robert E. Dudley, Ph.D., president and chief executive officer of Clarus Therapeutics continued, “Patient response to our oral T product observed to date in the clinic has been overwhelmingly positive. This is consistent with market research we conducted indicating a high level of interest in our oral T option among men who use current T-replacement products and their physicians. Pending successful completion of our ongoing Phase 3 clinical trial and FDA approval, Clarus is well-positioned to advance this new T-replacement product.”
The ongoing Phase 3 study (NCT01403116) has enrolled 325 men with low serum T (less than 300 ng/dL) in 30 sites in the U.S. and Germany.
Clarus anticipates receiving results from the trial in the third quarter of 2012.
About Clarus Therapeutics
Clarus is a privately held biopharmaceutical company focused on the development and commercialization of our oral T replacement product, currently undergoing Phase 3 clinical testing. According to the American Urological Association, 10% of men 40-to-60 years of age, and 20% over the age of 60 have low T levels. Common symptoms associated with low T may include mild depression, reduced sex drive and erectile function, increased body fat, and decreased energy, lean body mass, muscle strength and bone mineral density. For more information, please visit: www.clarustherapeutics.com.
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