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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)

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Not Applicable
Active, not recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-04-27
Last Posted Date
2024-05-24
Lead Sponsor
University of Chicago
Target Recruit Count
74
Registration Number
NCT01342367
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

Economic Analyses of the REDUCE Trial

Completed
Conditions
Benign Prostatic Hyperplasia
Neoplasms, Prostate
Cancer
Interventions
Drug: Placebo
First Posted Date
2011-04-18
Last Posted Date
2017-05-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01337258

AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Completed
Conditions
Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Interventions
First Posted Date
2011-02-18
Last Posted Date
2017-07-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
3977
Registration Number
NCT01299571
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

Phase 4
Completed
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2011-02-11
Last Posted Date
2018-08-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
742
Registration Number
NCT01294592
Locations
🇬🇧

GSK Investigational Site, High Heaton, Newcastle Upon Tyne, United Kingdom

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Phase 4
Completed
Conditions
Alcohol Abuse
Alcoholism
Alcohol Dependence
Interventions
Drug: Placebo
First Posted Date
2010-12-17
Last Posted Date
2017-03-20
Lead Sponsor
UConn Health
Target Recruit Count
47
Registration Number
NCT01262287
Locations
🇺🇸

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

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Phase 3
Completed
Conditions
Androgenetic Alopecia
Interventions
First Posted Date
2010-11-01
Last Posted Date
2018-08-10
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
917
Registration Number
NCT01231607
Locations
🇹🇭

GSK Investigational Site, Rajthevee Bangkok, Thailand

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

First Posted Date
2010-10-06
Last Posted Date
2014-03-31
Lead Sponsor
University of Washington
Target Recruit Count
46
Registration Number
NCT01215292
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

Dutasteride in Treating Patients With Prostate Cancer

Phase 2
Conditions
Prostate Cancer
First Posted Date
2010-09-02
Last Posted Date
2013-08-26
Lead Sponsor
University College London Hospitals
Target Recruit Count
42
Registration Number
NCT01193855
Locations
🇬🇧

University College of London Hospitals, London, England, United Kingdom

AVODART® Alopecia Post-marketing Surveillance (PMS)

Completed
Conditions
Alopecia
Interventions
First Posted Date
2009-10-30
Last Posted Date
2018-06-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
712
Registration Number
NCT01004809
Locations
🇰🇷

GSK Investigational Site, Daejeon, Korea, Republic of

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