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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)

To Evaluate the Pharmacokinetics and Safety of AD-208

Phase 1
Completed
Conditions
Androgenetic Alopecia
Interventions
First Posted Date
2020-01-02
Last Posted Date
2020-12-02
Lead Sponsor
Addpharma Inc.
Target Recruit Count
24
Registration Number
NCT04214808
Locations
🇰🇷

Kyungpook National University Hospital, Daegu, Korea, Republic of

Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy

Phase 2
Completed
Conditions
Alcohol Use Disorder
Interventions
Drug: Placebo Capsules
First Posted Date
2019-09-23
Last Posted Date
2025-05-09
Lead Sponsor
UConn Health
Target Recruit Count
180
Registration Number
NCT04098302
Locations
🇺🇸

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

Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Phase 1
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2017-08-07
Last Posted Date
2017-11-24
Lead Sponsor
Yuyu Pharma, Inc.
Target Recruit Count
36
Registration Number
NCT03240939
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

Phase 1
Completed
Conditions
Benign Prostate Hyperplasia
Interventions
First Posted Date
2016-07-20
Last Posted Date
2017-04-04
Lead Sponsor
Yuyu Pharma, Inc.
Target Recruit Count
28
Registration Number
NCT02839122

Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects

Phase 1
Completed
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2015-07-27
Last Posted Date
2018-06-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
56
Registration Number
NCT02509104
Locations
🇺🇸

GSK Investigational Site, Baltimore, Maryland, United States

Safety and Pharmacokinetic Characteristics of DKF-313

Phase 1
Completed
Conditions
Healthy
Benign Prostate Hyperplasia
Interventions
First Posted Date
2015-02-02
Last Posted Date
2021-07-06
Lead Sponsor
Dongkook Pharmaceutical Co., Ltd.
Target Recruit Count
54
Registration Number
NCT02352311
Locations
🇰🇷

Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

Phase 2
Withdrawn
Conditions
Prostate Cancer
Localized Prostate Cancer
First Posted Date
2014-06-10
Last Posted Date
2015-01-26
Lead Sponsor
Kenneth Pienta, MD
Registration Number
NCT02159690
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

ITT-5 Mechanisms of Spermatogenesis in Man

First Posted Date
2014-05-28
Last Posted Date
2019-12-18
Lead Sponsor
University of Washington
Registration Number
NCT02147964
Locations
🇺🇸

University of Washington Medical Center (Health Sciences), Seattle, Washington, United States

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

Phase 3
Completed
Conditions
Prostatic Hyperplasia
Interventions
First Posted Date
2014-02-10
Last Posted Date
2019-04-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
607
Registration Number
NCT02058368
Locations
🇨🇳

GSK Investigational Site, Tau-Yuan, Taiwan

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State

First Posted Date
2014-02-10
Last Posted Date
2018-09-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
77
Registration Number
NCT02058576
Locations
🇬🇧

GSK Investigational Site, Belfast, United Kingdom

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