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Dut5.4
Dutasteride Research
Mostly mechanism / observationalLimited safety
7 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Dutasteride studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from high-quality meta-analyses and randomised trials published 2006–2020 with a typical study size of 4,844 participants.
Based on 7 studies · 3 meta-analyses · 4 RCTs · 12,142 total participants
Confidence
High
By outcome
Hair loss & regrowth
Mostly mechanism / observational7 studies
Men's vitality
Mostly mechanism / observational4 studies
Prostate & BPH
Mostly mechanism / observational3 studies
Safety profile
Too few graded studies1 study
Older research base
Newest study from 2020 · Latest meta-analysis: 2020
200620132020
1RCTn=6,729 · very large study2010
Cancer was detected in 659 of 3305 men in the dutasteride group vs 858 of 3424 in the placebo group, a relative risk reduction of 22.8% over 4 years; during years 3 and 4 there were 12 Gleason 8–10 tumors in the dutasteride group vs 1 in the placebo group.
Andriole, Bostwick, Brawley, Gomella, Marberger, Montorsi · The New England journal of medicine (2010)
REDUCE: 4-year randomized double-blind placebo-controlled trial in 6729 men at increased prostate-cancer risk
Dutasteride cut overall biopsy-detected prostate cancer by ~23%
But a small excess of high-grade (Gleason 8–10) tumors in years 3–4 — the nuance that blocked a prevention indication
Dutasteride increased target area hair count versus placebo in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks.
Olsen, Hordinsky, Whiting, Stough, Hobbs, Ellis · Journal of the American Academy of Dermatology (2006)
Randomized placebo-controlled trial of 416 men comparing dutasteride doses, finasteride 5 mg, and placebo over 24 weeks
Scalp and serum DHT fell dose-dependently with dutasteride (dual type I + II inhibition)
3RCTn=153 · medium study2010
This study clearly showed that 0.5 mg of dutasteride improved hair growth and was relatively well tolerated for the treatment of male pattern hair loss.
Eun, Kwon, Yeon, Shin, Kim, Ro · Journal of the American Academy of Dermatology (2010)
Phase-III randomized double-blind placebo-controlled trial of 153 men over 6 months
Hair count rose +12.2/cm² with dutasteride 0.5 mg vs +4.7/cm² with placebo (P = .0319)
Superior to placebo on subject, investigator, and panel photographic assessment
Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe LUTS due to BPH and prostatic enlargement.
Roehrborn, Siami, Barkin, Damião, Major-Walker, Nandy · European urology (2010)
CombAT: 4-year multicenter randomized double-blind trial in 4844 men with symptomatic BPH and prostatic enlargement
Dutasteride (and combination with tamsulosin) reduced acute urinary retention and BPH-related surgery
Improved urinary symptoms, peak flow, and prostate volume over 4 years
Analysis results reiterate the efficacy and safety of 5α-reductase inhibitors for the treatment of AGA and may support the approval of dutasteride 0.5 mg as an additional treatment option.
Gupta, Charrette · Journal of dermatological treatment (2014)
Systematic review and network meta-analysis of finasteride and dutasteride RCTs for androgenetic alopecia
Active treatments were similarly effective on hair count and photographic assessment and not significantly different from placebo in eliciting sexual dysfunction
Supports dutasteride 0.5 mg as an effective AGA option
Seventeen randomized controlled trials with 17,494 patients were included; 5α-reductase inhibitors were associated with sexual dysfunction, erectile dysfunction, and decreased libido.
Liu, Zhao, Li, Li, Kang, Luo · The journal of sexual medicine (2016)
Systematic review and meta-analysis of 17 RCTs (17,494 patients) of 5α-reductase inhibitors for BPH and AGA, including 4 dutasteride trials
5ARIs increased sexual-dysfunction risk overall — but the association reached significance only in BPH patients; in men treated for hair loss (AGA) the estimates were not statistically significant (e.g. sexual dysfunction RR 1.21, 95% CI 0.85-1.72)
Quantifies the shared class sexual side-effect risk, while noting the hair-loss-specific signal is weaker and non-significant in the pooled AGA data