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Medical Letter on the CDC & FDA

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Hypogonadism



Trial finds effective treatment for testosterone replacement



September 5th, 2004

Columbia Laboratories, Inc., (NASDAQ:CBRX) announced that results of a Phase III study demonstrate that Striant (testosterone buccal system) (CIII) 30 mg is a safe and effective treatment for testosterone replacement in hypogonadal men when applied twice daily, with no dose adjustment required.

Study results appear in this month's issue of the Journal of Clinical Endocrinology and Metabolism.

Hypogonadism, a condition associated with a deficiency or absence of endogenous testosterone, affects nearly five million American men. The published study results provided the basis for the U.S. Food and Drug Administration (FDA) approval of Striant,...


Source: Medical Letter on the CDC & FDA (2004-09-05)

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