Clinical Trials

Dutasteride has been evaluated across multiple clinical trials spanning early to late phases, focusing primarily on benign prostatic hyperplasia, prostate cancer, urinary retention, and metabolic syndrome. Sponsored by pharmaceutical entities such as GlaxoSmithKline and Yuyu Pharma alongside academic institutions including Case Comprehensive Cancer Center, these trials vary in status from completed and recruiting to active, terminated, or withdrawn. Together, these studies highlight the broad clinical utility of dutasteride across diverse urologic and oncologic indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07420517 RECRUITING
Bladder Cancer
Paul Toren
 2026-03-25 PHASE2
NCT05705700 WITHDRAWN
Prostate Cancer
Masonic Cancer Center, University of Minnesota
 2023-02 PHASE2
NCT06916793 RECRUITING
Androgenetic Alopecia
Chong Kun Dang Pharmaceutical
 2025-04-08 PHASE3
NCT07421804 NOT_YET_RECRUITING
Acne Vulgaris
Assiut University
 2026-04
NCT06264414 NOT_YET_RECRUITING
Prostatic Hyperplasia, Benign; Erectile Dysfunction
EMS
 2025-02 PHASE3
NCT05513365 RECRUITING
Salivary Duct Carcinoma
Radboud University Medical Center
 2022-09-27 PHASE2
NCT07065682 RECRUITING
BPH (Benign Prostatic Hyperplasia)
Universitas Diponegoro
 2023-07-01 PHASE1
NCT06233227 UNKNOWN
Healthy Subjects
Bio-innova Co., Ltd
 2024-09-24 PHASE1
NCT04098302 COMPLETED
Alcohol Use Disorder
UConn Health
 2019-10-15 PHASE2; PHASE3
NCT06110377 UNKNOWN
Androgenic Alopecia
Clinica Dermatologica Arbache ltda
 2023-10-30 PHASE4
NCT02213107 COMPLETED
Prostate Cancer
University of Rochester
 2014-09 PHASE2
NCT04677855 TERMINATED
Prostate Cancer
Pellficure Pharmaceuticals, Inc
 2021-03-30 PHASE1
NCT05599243 COMPLETED
Male Androgenetic Alopecia
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
 2022-09-29 PHASE2
NCT04947631 COMPLETED
Benign Prostatic Hyperplasia
Dongkook Pharmaceutical Co., Ltd.
 2021-07-27 PHASE3
NCT06677177 COMPLETED
Lower Urinary Tract Symptoms
ALI KAMAL M. SAMI
 2016-02-16
NCT02147964 WITHDRAWN
Gonadotropin Deficiency
University of Washington
 2019-06 PHASE2
NCT04729491 COMPLETED
Covid19
Corpometria Institute
 2020-06-30 PHASE2; PHASE3
NCT01342367 ACTIVE_NOT_RECRUITING
Prostate Cancer
University of Chicago
 2010-12-17
NCT04756206 COMPLETED
Dutasteride; Category IIIB Chronic Prostatitis
Ain Shams University
 2019-01-01 PHASE2; PHASE3
NCT00866554 COMPLETED
Prostate Cancer; Erectile Dysfunction; Lower Urinary Tract Symptoms
CHU de Quebec-Universite Laval
 2009-03 PHASE2
NCT03669692 Withdrawn
Prostatic Hyperplasia Benign|Metabolic Syndrome
Complexo Hospitalario Universitario de A Coruña
 2018-07-10 Not Applicable
NCT01758523 COMPLETED
Alcoholism; Alcohol Abuse; Alcohol Dependence
UConn Health
 2013-01 PHASE4
NCT03240939 COMPLETED
Benign Prostatic Hyperplasia
Yuyu Pharma, Inc.
 2017-03-27 PHASE1
NCT02058368 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2014-02-10 PHASE3
NCT01653925 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms; Low Grade Prostate Cancer
CHU de Quebec-Universite Laval
 2010-10-28
NCT02839122 COMPLETED
Benign Prostate Hyperplasia
Yuyu Pharma, Inc.
 2016-05 PHASE1
NCT02839122 Completed
Benign Prostate Hyperplasia
Yuyu Pharma Inc.
 2016-05 Phase 1
NCT01777269 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2013-02-18 PHASE4
NCT02014584 COMPLETED
Alopecia
Stiefel, a GSK Company
 2014-07-02 PHASE3
NCT01393730 COMPLETED
Prostate Cancer
Mary-Ellen Taplin, MD
 2011-09 PHASE2
NCT02578953 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2015-09-09 PHASE1
NCT02509104 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2015-07-30 PHASE1
NCT01673490 TERMINATED
Prostatic Hyperplasia
GlaxoSmithKline
 2012-06-29 PHASE4
NCT02184585 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2014-07-10 PHASE1
NCT02058576 COMPLETED
Urologic Diseases
GlaxoSmithKline
 2014-02-11 PHASE1
NCT02159690 WITHDRAWN
Prostate Cancer; Localized Prostate Cancer
Kenneth Pienta, MD
 2014-09 PHASE2
NCT02052713 COMPLETED
Urologic Diseases
GlaxoSmithKline
 2014-02-19 PHASE1
NCT00939120 COMPLETED
Benign Prostatic Hyperplasia (BPH)
Siami, Paul F., M.D.
 2009-07 PHASE4
NCT01831791 COMPLETED
Alopecia
GlaxoSmithKline
 2013-04-14 PHASE3
NCT00805701 COMPLETED
Prostate Cancer
Bay State Clinical Trials, Inc.
 2009-01 PHASE4
NCT00082043 COMPLETED
Premenstrual Syndrome; PMS; Healthy; Depression
National Institute of Mental Health (NIMH)
 2004-03-31 PHASE1
NCT01957189 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2013-10-25 PHASE1
NCT01929330 COMPLETED
Alopecia
GlaxoSmithKline
 2013-09-23 PHASE1
NCT01942551 COMPLETED
Benign Prostate Hyperplasia
Dongkook Pharmaceutical Co., Ltd.
 2013-09 PHASE1
NCT01547299 COMPLETED
Prostate Cancer
Pfizer
 2012-03-31 PHASE2
NCT01294592 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2010-12-22 PHASE4
NCT01923090 UNKNOWN
Healthy Volunteers
University of Birmingham
 2012-08 PHASE2
NCT00668642 COMPLETED
Prostate Cancer
Endeavor Health
 2007-03 PHASE2
NCT00953576 TERMINATED
Prostate Cancer
Dana-Farber Cancer Institute
 2009-09-29 PHASE1; PHASE2
NCT00470834 COMPLETED
Neoplasms, Prostate
GlaxoSmithKline
 2007-05 PHASE4
NCT00985738 TERMINATED
Prostate Cancer
University of Colorado, Denver
 2009-09 PHASE2
NCT01657851 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2012-08-23 PHASE1
NCT01262287 COMPLETED
Alcoholism; Alcohol Abuse; Alcohol Dependence
UConn Health
 2011-01 PHASE4
NCT01368003 WITHDRAWN
Adenocarcinoma of the Prostate
Toni Choueiri, MD
 2011-04 PHASE2
NCT00853697 COMPLETED
Prostate Cancer; Castration-resistant, Metastatic
Memorial Sloan Kettering Cancer Center
 2009-03 PHASE2
NCT01495026 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2011-11-06 PHASE1
NCT00752869 COMPLETED
Hypogonadism
The Miriam Hospital
 2008-09 PHASE4
NCT01215292 COMPLETED
Healthy Males
University of Washington
 2011-01 PHASE1; PHASE2
NCT01231607 COMPLETED
Androgenetic Alopecia
GlaxoSmithKline
 2010-10-28 PHASE3
NCT00673127 COMPLETED
Prostate Cancer
Beth Israel Deaconess Medical Center
 2005-02 PHASE2
NCT01193855 UNKNOWN
Prostate Cancer
University College London Hospitals
 2010-06 PHASE2
NCT00490555 COMPLETED
Healthy
University of Washington
 2009-01 PHASE2; PHASE3
NCT01471678 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2011-06-30 PHASE1
NCT01577693 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2011-05-12 PHASE1
NCT01254071 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2010-09-10 PHASE1
NCT00558363 COMPLETED
Neoplasms, Prostate; Prostate Cancer After a Radical Treatment
GlaxoSmithKline
 2007-11 PHASE2
NCT00780754 COMPLETED
Prostate Cancer
Kaunas University of Medicine
 2007-04 PHASE3
NCT00734656 COMPLETED
Alcohol Related Disorders; Alcoholism; Alcohol Abuse
UConn Health
 2007-03
NCT00398281 COMPLETED
Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2006-11 PHASE3
NCT00298155 COMPLETED
Cancer; Prostate Neoplasms
University of Washington
 2006-07 PHASE2
NCT00194675 COMPLETED
Hypogonadism; Benign Prostatic Hyperplasia
University of Washington
 2005-03 PHASE4
NCT00363311 COMPLETED
Neoplasms, Prostate
GlaxoSmithKline
 2006-07 PHASE4
NCT00493987 COMPLETED
Healthy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2002-11 PHASE4
NCT00303446 COMPLETED
Kennedy's Disease; Spinal and Bulbar Muscular Atrophy
National Institute of Neurological Disorders and Stroke (NINDS)
 2006-03 PHASE2
NCT00553878 COMPLETED
Prostate Cancer
Canadian Urology Research Consortium
 2007-03 PHASE2; PHASE3
NCT04545450 COMPLETED
Transgenderism; Hypogonadism
Unita Complessa di Ostetricia e Ginecologia
 2008-11-04 PHASE3
NCT00690950 UNKNOWN
Benign Prostatic Hyperplasia
Urologic Consultants of Southeastern PA
 2008-05 PHASE4
NCT00701779 COMPLETED
Benign Prostatic Hyperplasia
Siami, Paul F., M.D.
 2005-09 PHASE4
NCT00382356 COMPLETED
Benign Prostatic Hypertrophy
North Florida/South Georgia Veterans Health System
 2004-11
NCT00983554 UNKNOWN
Obesity; Insulin Resistance
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2005-06
NCT00431626 TERMINATED
Benign Prostatic Hyperplasia
Northwestern University
 2006-10 PHASE3
NCT00090103 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2003-11 PHASE3
NCT00827814 COMPLETED
Benign Prostatic Hyperplasia
Samsung Medical Center
 2006-06 PHASE4
NCT00527605 COMPLETED
Benign Prostatic Hyperplasia; Prostatic Hyperplasia
GlaxoSmithKline
 2007-10 PHASE3
NCT00056407 COMPLETED
Neoplasms, Prostate
GlaxoSmithKline
 2003-03 PHASE3
NCT00706966 COMPLETED
Nonmalignant Neoplasm; Prostate Cancer
University of California, San Francisco
 2005-06
NCT00880672 COMPLETED
Benign Prostatic Hyperplasia
Seoul National University Hospital
 2008-01 PHASE4
NCT00309855 COMPLETED
Aging
Mayo Clinic
 2005-12 PHASE1
NCT00537654 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2007-10-18 PHASE1
NCT00680680 COMPLETED
Urinary Retention; Benign Prostatic Hyperplasia
Franklin D. Gaylis, MD Inc.
 2004-05
NCT00441116 COMPLETED
Alopecia
GlaxoSmithKline
 2006-12-15 PHASE3
NCT00368979 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2006-02-17 PHASE3
NCT00398580 COMPLETED
Hypogonadism; Hypogonadism, Male
GlaxoSmithKline
 2006-10 PHASE2
NCT00375765 COMPLETED
Benign Prostatic Hyperplasia; Prostate Cancer
GlaxoSmithKline
 2005-04 PHASE4
NCT00399165 COMPLETED
Contraception
University of Washington
 2006-11 PHASE1; PHASE2
NCT00403000 COMPLETED
Prostate Cancer
Roswell Park Cancer Institute
 2004-12 PHASE2
NCT00802321 COMPLETED
Alcohol Related Disorders; Alcoholism; Alcohol Abuse
UConn Health
 2006-04
NCT00161421 COMPLETED
Contraception; Hypogonadism
University of Washington
 2005-03 PHASE2
NCT00244309 COMPLETED
Prostate Cancer
Case Comprehensive Cancer Center
 2005-11 PHASE3
NCT00146146 COMPLETED
Transsexualism
Unita Complessa di Ostetricia e Ginecologia
 2005-05 PHASE3
NCT00421421 TERMINATED
Benign Prostatic Hyperplasia
GlaxoSmithKline
 2007-03 PHASE4
NCT00400335 COMPLETED
Hypogonadism; Hypogonadism, Male
GlaxoSmithKline
 2006-10 PHASE1
NCT00062790 COMPLETED
Prostatic Hyperplasia
GlaxoSmithKline
 2003-10 PHASE4
NCT00274417 UNKNOWN
Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
Urology of Virginia
 2006-01

(data from https://clinicaltrials.gov, updated on 2026-03-30)

Check the Dutasteride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dutasteride acts as a dual-isoform inhibitor of type 1 and type 2 5-alpha reductase, preventing the enzymatic conversion of testosterone into dihydrotestosterone and thereby suppressing androgen receptor-mediated signaling in target cells. This reduction in intracellular dihydrotestosterone limits androgenic drive and prostate tissue growth, providing the physiological basis for its therapeutic evaluation in benign prostatic hyperplasia and prostate cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.