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Dutasteride Phase 2 Trial Results

These are the results of the GlaxoSmithKline testing of GI198745 otherwise known as Dutasteride for hair loss. These results were taken from the Phase II study required for FDA approval. The Phase III trials for hair loss are currently on hold, but the NDA (New Drug Application) for BPH was submitted to the FDA in December 2000. This mean that if approved by the FDA, Dutasteride could be available by the end of 2001 or early 2002 for the treatment of an enlarged prostate or BPH.

This graph shows that after six month of treatment, the hair counts measured in a 1 inch diameter circle increased by about ~96 hairs with 0.5mg Dutasteride, compared to about ~72 hairs with 5mg Finasteride. The hair counts increased significantly with an increase in dosage with the biggest gain being ~108 hairs with a dose of 2.5mg Dutasteride.

So compared to 5mg Finasteride (Propecia), 2.5 mg Dutasteride grew about 1.5 times as many hairs.

DUTASTERIDE PHASE 2 HAIR COUNTS