BioXell announces start of Phase IIa trial of Elocalcitol in Male Infertility

20-Nov-2007

BioXell S.p.A. announced the enrollment of the first patient in its Phase IIa trial of Elocalcitol in male infertility, a widespread condition currently with no effective treatment. The trial is designed to test the ability of Elocalcitol to improve sperm quality in infertile male patients. Results are expected for the end of 2008.

The randomized, double-blind, placebo-controlled, parallel group study is being conducted at 8 Italian centers that are highly specialized in infertility, under the coordination of Professor Andrea Lenzi of the University of Rome. The trial will involve a total of 234 infertile male patients with poor sperm quality and no known specific causes of infertility, and will test Elocalcitol at doses of 75 mcg and 150 mcg versus placebo for an effect on various sperm parameters. Treatment duration is 4 months, preceded by 3 months of pre-screening/washout and one week of medication-free run-in, and with a one month follow-up after treatment. The primary endpoint is total sperm motility (percentage), with secondary endpoints including forward motility (percentage), total and forward motility (absolute value), morphology (atypical cells), conception rate, IL-8 seminal plasma levels, leukocytes in the semen, and safety and tolerability.

Infertile men with leukospermia (increased number of seminal leukocytes) have previously been found to have significantly elevated levels of the chemokine IL-8 in their seminal plasma. Seminal plasma IL-8 levels have, in turn, been shown to be inversely correlated, with high significance, with several measures of semen quality. In a separate clinical trial completed last year, BioXell found that Elocalcitol treatment induced a significant decrease in IL-8 levels in the seminal plasma of patients suffering from chronic prostatitis, a disease which is often associated with infertility. These elements provide a strong rationale for carrying out the newly initiated clinical study, in view of a possible use of Elocalcitol to treat male infertility.

https://www.bionity.com/en/news/74716/bioxell-announces-start-of-phase-iia-trial-of-elocalcitol-in-male-infertility.html