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Drug Development
Clinical study contracts for U.S. trials of two drugs awarded to CRO
October 23rd, 2005
Zonagen, Inc. (ZONA) announced that the company has awarded contracts for its next planned U.S. studies for both Proellex and Androxal. Pending review by the U.S. Food and Drug Administration (FDA) this fall, Zonagen intends to conduct a 150 patient Phase 2 trial of Proellex for the treatment of uterine fibroids and a 210 patient Phase 3 trial of Androxal for the treatment of testosterone deficiency. The company currently plans on using up to 20 clinical sites for each study. Upon successful completion of 3 month preclinical safety studies, Zonagen hopes to submit the IND for a Phase 2 trial of Proellex and the IND update and Special Protocol...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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