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Oral Testosterone Replacement (CLR-610) Shows Positive Results in Phase III Study
Average serum testosterone levels increased in 87% of patients (Sept. 25)
On September 25, Clarus Therapeutics, Inc., based in Northbrook, Ill., reported top-line results from its ongoing phase III study of CLR-610, the company’s oral testosterone replacement product.
In the study’s 90-day treatment phase, 123 (87%) of 141 men treated with CLR-610 achieved average serum testosterone levels (C-avg) in the normal range (between 300 and 1,000 ng/dL) — the trial’s primary efficacy endpoint. The C-avg in men treated with CLR-610 was 624 ng/dL. In comparison, 117 (80%) of 146 men treated with testosterone gel in the active-comparator arm achieved C-avg in the normal range. The C-avg in men treated with testosterone gel was 480 ng/dL.
Consistent with phase II results, there was no evidence of liver toxicity in men treated with CLR-610 or testosterone gel.
The phase III study enrolled 325 men with low serum testosterone (less than 300 ng/dL) in the U.S. and Germany. The men were randomly assigned to receive CLR-610 or testosterone gel. The primary endpoint of the ongoing study is the percentage of men who achieve normal serum testosterone levels after the administration of CLR-610 for 90 days. At least 75% of men on day 90 must have average serum testosterone levels in the normal range to meet current FDA efficacy guidance for testosterone replacement products.
For more information, visit the Clarus Therapeutics, Inc. Web site.