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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)

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State

First Posted Date
2014-02-03
Last Posted Date
2018-09-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
78
Registration Number
NCT02052713
Locations
🇬🇧

GSK Investigational Site, Belfast, United Kingdom

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Phase 3
Completed
Conditions
Alopecia
Interventions
Drug: Placebo
First Posted Date
2013-12-18
Last Posted Date
2018-10-11
Lead Sponsor
Stiefel, a GSK Company
Target Recruit Count
117
Registration Number
NCT02014584
Locations
🇨🇳

GSK Investigational Site, Taipei, Taiwan

This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples

Phase 1
Completed
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2013-10-08
Last Posted Date
2018-06-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
24
Registration Number
NCT01957189
Locations
🇨🇳

GSK Investigational Site, Shanghai, China

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

Phase 1
Completed
Conditions
Benign Prostate Hyperplasia
Interventions
First Posted Date
2013-09-16
Last Posted Date
2015-01-26
Lead Sponsor
Dongkook Pharmaceutical Co., Ltd.
Target Recruit Count
47
Registration Number
NCT01942551
Locations
🇰🇷

Chungnam National University Hospital, Daejeon, Korea, Republic of

Finasteride, Dutasteride and Insulin Action

Phase 2
Conditions
Healthy Volunteers
Interventions
First Posted Date
2013-08-14
Last Posted Date
2013-08-14
Lead Sponsor
University of Birmingham
Target Recruit Count
12
Registration Number
NCT01923090
Locations
🇬🇧

Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital, Birmingham, West Midlands, United Kingdom

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

Phase 3
Completed
Conditions
Alopecia
Interventions
First Posted Date
2013-04-15
Last Posted Date
2018-06-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
120
Registration Number
NCT01831791
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Phase 3
Terminated
Conditions
Chronic Prostatitis
Benign Prostatic Hyperplasia
Interventions
Drug: Placebo
First Posted Date
2013-04-12
Last Posted Date
2014-10-22
Lead Sponsor
Dr. J. Curtis Nickel
Target Recruit Count
1
Registration Number
NCT01830829
Locations
🇨🇦

Centre for Applied Urological Research, Kingston, Ontario, Canada

Prospective Sexual Function Study for BPH Subjects

Phase 4
Completed
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2013-01-28
Last Posted Date
2018-08-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
489
Registration Number
NCT01777269
Locations
🇪🇸

GSK Investigational Site, Vitoria- Gasteiz, Spain

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Phase 4
Completed
Conditions
Alcoholism
Alcohol Abuse
Alcohol Dependence
Interventions
Drug: sugar pill
First Posted Date
2013-01-01
Last Posted Date
2019-04-26
Lead Sponsor
UConn Health
Target Recruit Count
189
Registration Number
NCT01758523
Locations
🇺🇸

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

Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia

Phase 4
Terminated
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2012-08-28
Last Posted Date
2018-08-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
59
Registration Number
NCT01673490
Locations
🇻🇳

GSK Investigational Site, Ho Chi Minh, Vietnam

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