MedPath

Dutasteride

Generic Name
Dutasteride
Brand Names
Avodart, Jalyn
Drug Type
Small Molecule
Chemical Formula
C27H30F6N2O2
CAS Number
164656-23-9
Unique Ingredient Identifier
O0J6XJN02I
Background

Dutasteride is an oral synthetic 4-azasteroid commonly marketed under the trade name Avodart. It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner. Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland. Dutasteride was approved by the FDA in 2001 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men as monotherapy or in combination with the α-adrenergic antagonist tamsulosin to enhance the therapeutic response. Its clinical efficacy against benign prostate hyperplasia in male patients is comparable to that of finasteride, a specific type II 5α-reductase inhibitor. However, unlike finasteride, dutasteride is not yet indicated for the treatment of androgenic alopecia although it was demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia.

Indication

Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with tamsulosin.

Associated Conditions
Benign Prostatic Hyperplasia (BPH), Symptomatic benign prostatic hyperplasia (BPH)

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
Other: Placebo
First Posted Date
2009-09-28
Last Posted Date
2016-05-17
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
16
Registration Number
NCT00985738
Locations
🇺🇸

University of Colorado Hospital, Aurora, Colorado, United States

Metabolic Effects of Steroids in Obese Men

Not Applicable
Conditions
Obesity
Insulin Resistance
Interventions
First Posted Date
2009-09-24
Last Posted Date
2011-03-16
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
57
Registration Number
NCT00983554
Locations
🇺🇸

University of California, San Diego, San Diego, California, United States

🇺🇸

VA San Diego Healthcare System, San Diego, California, United States

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Phase 1
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2009-08-06
Last Posted Date
2018-09-04
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
11
Registration Number
NCT00953576
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia (BPH)
Interventions
First Posted Date
2009-07-14
Last Posted Date
2015-05-01
Lead Sponsor
Siami, Paul F., M.D.
Target Recruit Count
46
Registration Number
NCT00939120
Locations
🇺🇸

Deaconess Clinic Gateway Health Center, Newburgh, Indiana, United States

ARI103094-Follow-Up Study for REDUCE Study Subjects

Completed
Conditions
Neoplasms, Prostate
Interventions
First Posted Date
2009-04-20
Last Posted Date
2017-07-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
2795
Registration Number
NCT00883909
Locations
🇬🇧

GSK Investigational Site, Waterloo, Liverpool, United Kingdom

Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2009-04-14
Last Posted Date
2013-06-12
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
40
Registration Number
NCT00880672

Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2009-01-23
Last Posted Date
2009-06-11
Lead Sponsor
Samsung Medical Center
Target Recruit Count
36
Registration Number
NCT00827814
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation

Phase 4
Completed
Conditions
Prostate Cancer
Interventions
Drug: Placebo
First Posted Date
2008-12-10
Last Posted Date
2014-05-14
Lead Sponsor
Bay State Clinical Trials, Inc.
Target Recruit Count
40
Registration Number
NCT00805701
Locations
🇺🇸

Bay State Clinical Trials, Inc., Watertown, Massachusetts, United States

Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects

Not Applicable
Completed
Conditions
Alcohol Related Disorders
Alcoholism
Alcohol Abuse
Interventions
First Posted Date
2008-12-04
Last Posted Date
2010-09-23
Lead Sponsor
UConn Health
Target Recruit Count
40
Registration Number
NCT00802321
Locations
🇺🇸

Unversity of Connecticut Health Center, Farmington, Connecticut, United States

Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Procedure: prostate biopsy
First Posted Date
2008-10-28
Last Posted Date
2018-03-06
Lead Sponsor
Kaunas University of Medicine
Target Recruit Count
200
Registration Number
NCT00780754
Locations
🇱🇹

Urology dep. of Kaunas University of Medicine, Kaunas, Lithuania

© Copyright 2025. All Rights Reserved by MedPath