Clark · The Journal of clinical endocrinology and metabolism 2004 · Randomized controlled trial · n=399

Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor.

Cited 467 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled trial comparing multiple doses of dutasteride with finasteride and placebo.

PubMed 15126539 · doi:10.1210/jc.2003-030330 · record verified 2026-08-29

What was done

A total of 399 men with benign prostatic hyperplasia (BPH) were randomized to 24 weeks of once-daily treatment with dutasteride (0.01, 0.05, 0.5, 2.5, or 5.0 mg), finasteride (5 mg), or placebo to compare suppression of serum dihydrotestosterone (DHT).

What was found

Mean serum DHT decreased by 98.4 ± 1.2% with 5.0 mg dutasteride and 94.7 ± 3.3% with 0.5 mg dutasteride, compared with 70.8 ± 18.3% with 5 mg finasteride (P < 0.001). Dutasteride showed greater suppression and less variability. Serum testosterone increased but remained within the normal range across all treatment groups, and dutasteride was well tolerated with an adverse event profile similar to placebo.

Why it matters

Dual inhibition of type 1 and type 2 5alpha-reductase by dutasteride achieves near-complete serum DHT suppression, significantly outperforming the selective type 2 inhibition of finasteride.

Limits

The abstract focuses on hormonal endpoints and does not report clinical efficacy outcomes, such as changes in prostate volume, urinary flow rates, or symptom scores. Specific numerical results for the lower dutasteride doses (0.01 and 0.05 mg) and detailed adverse event rates are omitted.

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