Key Sources & References

This page lists the primary peer-reviewed studies, FDA documents, and institutional references that support the clinical claims on Dutasteride.com. All content follows our Editorial Policy, which requires every clinical claim to be supported by a Tier 1 or Tier 2 source.

FDA & Regulatory Documents

Pivotal Clinical Trials: Hair Loss (AGA)

  • Olsen EA, Hordinsky M, Whiting D, et al. The importance of dual 5α-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride. J Am Acad Dermatol. 2006;55(6):1014–1023. PubMed 17110217
  • Eun HC, Kwon OS, Yeon JH, et al. Efficacy, safety, and tolerability of dutasteride 0.5 mg once daily in male patients with male pattern hair loss: a randomized, double-blind, placebo-controlled, phase III study. J Am Acad Dermatol. 2010;63(2):252–258. PubMed 20605255
  • Shanshanwal SJ, Dhurat RS. Superiority of dutasteride over finasteride in hair regrowth and reversal of miniaturization in men with androgenetic alopecia: A randomized controlled open-label, evaluator-blinded study. Indian J Dermatol Venereol Leprol. 2017;83(1):47–54. PubMed 27549867
  • Jung JY, Yeon JH, Choi JW, et al. Effect of dutasteride 0.5 mg/d in men with androgenetic alopecia recalcitrant to finasteride. Int J Dermatol. 2014;53(11):1351–1357. PubMed 24898559
  • Gubelin Harcha W, Barboza Martínez J, Tsai TF, et al. A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia. J Am Acad Dermatol. 2014;70(3):489–498.e3. PubMed 24411083

BPH Clinical Trials

  • Roehrborn CG, Boyle P, Nickel JC, Hoefner K, Andriole G; ARIA3001 ARIA3002 and ARIA3003 Study Investigators. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with bph/">benign prostatic hyperplasia. Urology. 2002;60(3):434–441. PubMed 12350480
  • Roehrborn CG, Siami P, Barkin J, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008;179(2):616–621. PubMed 18082216
  • Siami P, Roehrborn CG, Barkin J, et al. Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. Contemp Clin Trials. 2007;28(6):770–779. PubMed 17761460

REDUCE Trial: Long-Term Safety

  • Andriole GL, Bostwick DG, Brawley OW, et al. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010;362(13):1192–1202. PubMed 20357281. 4-year, 8,231-patient prostate cancer chemoprevention trial; primary source for incidence data.

Pharmacokinetics & Mechanism

  • Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab. 2004;89(5):2179–2184. PubMed 15126539
  • Bramson HN, Hermann D, Batchelor KW, Lee FW, James MK, Frye SV. Unique preclinical characteristics of GG745, a potent dual inhibitor of 5AR. J Pharmacol Exp Ther. 1997;282(3):1496–1502. PubMed 9316864
  • Gupta AK, Charrette A. The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride. J Dermatolog Treat. 2014;25(2):156–161. PubMed 23768246

Topical Dutasteride

  • Piraccini BM, Blume-Peytavi U, Scarci F, et al. Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial. J Eur Acad Dermatol Venereol. 2022;36(2):286–294. PubMed 34634163
  • Panuganti VK, Kumar Madala P, Ramalingayya Grandhi V, et al. A randomized, double-blind, placebo and active controlled phase II study to evaluate the safety and efficacy of novel dutasteride topical solution (0.01%, 0.02%, and 0.05% w/v) in male subjects with androgenetic alopecia. Cureus. 2025;17(8):e89309. PubMed 40909044

Women, Pregnancy & Special Populations

  • Mella JM, Perret MC, Manzotti M, Catalano HN, Guyatt G. Efficacy and safety of finasteride therapy for androgenetic alopecia: a systematic review. Arch Dermatol. 2010;146(10):1141–1150. PubMed 20956649
  • Camacho-Martínez FM. Hair loss in women. Semin Cutan Med Surg. 2009;28(1):19–32. PubMed 19341939

Institutional Resources

  • Mayo Clinic. Dutasteride (Oral Route). Patient drug information.
  • DailyMed (NIH/NLM). Dutasteride labelling. Current FDA-approved labelling for every marketed dutasteride product.
  • MedlinePlus (NIH/NLM). Dutasteride. National Library of Medicine.
  • LiverTox (NIH/NLM). Dutasteride: LiverTox entry.
  • StatPearls (NCBI). Dutasteride. Treasure Island (FL): StatPearls Publishing; 2024.

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