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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)

Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment

First Posted Date
2004-08-26
Last Posted Date
2017-02-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
4844
Registration Number
NCT00090103
Locations

GSK Investigational Site

Dutasteride to Treat Women With Menstrually Related Mood Disorders

Phase 1
Completed
Conditions
Premenstrual Syndrome
Depression
PMS
Healthy
Interventions
Drug: Placebo oral capsule
First Posted Date
2004-04-28
Last Posted Date
2019-12-17
Lead Sponsor
National Institute of Mental Health (NIMH)
Target Recruit Count
34
Registration Number
NCT00082043
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Phase 4
Completed
Conditions
Prostatic Hyperplasia
First Posted Date
2003-06-17
Last Posted Date
2016-09-15
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
50
Registration Number
NCT00062790
Locations
🇺🇸

GSK Investigational Site, Richmond, Virginia, United States

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Phase 3
Completed
Conditions
Neoplasms, Prostate
Interventions
Drug: Placebo
First Posted Date
2003-03-13
Last Posted Date
2016-09-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
8231
Registration Number
NCT00056407
Locations

GSK Investigational Site

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