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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)

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

Phase 3
Not yet recruiting
Conditions
Androgenetic Alopecia
Interventions
Drug: CKD-843 dose#1
Drug: CKD-843 dose#2
Drug: Placebo of CKD-843 dose
Drug: Placebo of Dutasteride Capsule
First Posted Date
2025-04-08
Last Posted Date
2025-04-08
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
288
Registration Number
NCT06916793
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

Phase 2
Withdrawn
Conditions
Prostate Cancer
Interventions
First Posted Date
2023-01-31
Last Posted Date
2023-02-27
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Registration Number
NCT05705700

Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

Phase 2
Active, not recruiting
Conditions
Male Androgenetic Alopecia
Interventions
Other: Placebo
First Posted Date
2022-10-31
Last Posted Date
2023-05-30
Lead Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Target Recruit Count
45
Registration Number
NCT05599243
Locations
🇪🇸

Hospital Ramón y Cajal, Madrid, Spain

Phase II Dutasteride in Combination With CAB vs CAB in SDC

Phase 2
Recruiting
Conditions
Salivary Duct Carcinoma
Interventions
First Posted Date
2022-08-24
Last Posted Date
2024-11-21
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
26
Registration Number
NCT05513365
Locations
🇳🇱

Radboudumc, Nijmegen, Gelderland, Netherlands

Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Phase 3
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2021-07-01
Last Posted Date
2023-09-21
Lead Sponsor
Dongkook Pharmaceutical Co., Ltd.
Target Recruit Count
667
Registration Number
NCT04947631
Locations
🇰🇷

Ewha Womans University mokdong Hospital, Seoul, Korea, Republic of

A Study to Evaluate the Efficacy and Safety of AD-208

Phase 3
Completed
Conditions
Androgenetic Alopecia
Interventions
Drug: placebo of AD-208
Drug: placebo of AD-2081
First Posted Date
2021-04-01
Last Posted Date
2023-07-21
Lead Sponsor
Addpharma Inc.
Target Recruit Count
139
Registration Number
NCT04825561
Locations
🇰🇷

The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Korea, Republic of

Role of Dutasteride in Treatment of Chronic Prostatitis

Phase 2
Completed
Conditions
Category IIIB Chronic Prostatitis
Dutasteride
Interventions
First Posted Date
2021-02-16
Last Posted Date
2021-02-16
Lead Sponsor
Ain Shams University
Target Recruit Count
50
Registration Number
NCT04756206
Locations
🇪🇬

Urology department - ain shams university, Cairo, Egypt

EAT-DUTA AndroCoV Trial

Phase 2
Completed
Conditions
Covid19
Interventions
First Posted Date
2021-01-28
Last Posted Date
2021-01-28
Lead Sponsor
Corpometria Institute
Target Recruit Count
138
Registration Number
NCT04729491
Locations
🇧🇷

Corpometria Institute, Brasília, DF, Brazil

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

Phase 1
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2020-12-21
Last Posted Date
2024-04-10
Lead Sponsor
Pellficure Pharmaceuticals, Inc
Target Recruit Count
7
Registration Number
NCT04677855
Locations
🇺🇸

Nebraska Cancer Specialist, Omaha, Nebraska, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇦🇺

St. George Private Hospital, Kogarah, New South Wales, Australia

and more 1 locations

Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

Phase 3
Completed
Conditions
Transgenderism
Hypogonadism
Interventions
First Posted Date
2020-09-11
Last Posted Date
2020-09-11
Lead Sponsor
Unita Complessa di Ostetricia e Ginecologia
Target Recruit Count
16
Registration Number
NCT04545450
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