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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)

The Role of 5-alpha Reductase in Mediating Testosterone Actions

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2007-06-29
Last Posted Date
2010-05-13
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
184
Registration Number
NCT00493987
Locations
🇺🇸

Boston University Medical Center, Boston, Massachusetts, United States

PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue

Phase 2
Completed
Conditions
Healthy
Interventions
Other: Placebo Testosterone gel
Drug: Depo-Medroxyprogesterone (DMPA)
Other: Placebo dutasteride
Other: Placebo DMPA
First Posted Date
2007-06-22
Last Posted Date
2013-11-15
Lead Sponsor
University of Washington
Target Recruit Count
32
Registration Number
NCT00490555
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

Phase 4
Completed
Conditions
Neoplasms, Prostate
Interventions
First Posted Date
2007-05-08
Last Posted Date
2017-02-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
127
Registration Number
NCT00470834
Locations
🇨🇦

GSK Investigational Site, Quebec, Canada

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

Phase 3
Completed
Conditions
Alopecia
Interventions
First Posted Date
2007-02-28
Last Posted Date
2018-08-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
153
Registration Number
NCT00441116

A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

Phase 3
Terminated
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2007-02-06
Last Posted Date
2015-10-28
Lead Sponsor
Northwestern University
Target Recruit Count
4
Registration Number
NCT00431626

Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter

Phase 4
Terminated
Conditions
Benign Prostatic Hyperplasia
First Posted Date
2007-01-12
Last Posted Date
2007-11-27
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
276
Registration Number
NCT00421421
Locations
🇬🇧

GSK Clinical Trials Call Centre, Derby, United Kingdom

🇬🇧

GSK Clinical Trials Call Center, Wakefield, United Kingdom

Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Phase 2
Completed
Conditions
Prostate Cancer
First Posted Date
2006-11-23
Last Posted Date
2013-05-01
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
27
Registration Number
NCT00403000
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride

Phase 1
Completed
Conditions
Hypogonadism
Hypogonadism, Male
First Posted Date
2006-11-16
Last Posted Date
2012-06-04
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
60
Registration Number
NCT00400335
Locations
🇺🇸

GSK Investigational Site, Tacoma, Washington, United States

Oral Androgens in Man-4: (Short Title: Oral T-4)

Phase 1
Completed
Conditions
Contraception
Interventions
First Posted Date
2006-11-14
Last Posted Date
2008-09-22
Lead Sponsor
University of Washington
Target Recruit Count
20
Registration Number
NCT00399165
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Other: placebo
First Posted Date
2006-11-10
Last Posted Date
2014-01-10
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
450
Registration Number
NCT00398281
Locations
🇺🇸

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States

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