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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR DUTASTERIDE


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505(b)(2) Clinical Trials for Dutasteride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT05599243 ↗ Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia. Recruiting Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Phase 2 2022-09-29 Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dutasteride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00056407 ↗ "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk Completed GlaxoSmithKline Phase 3 2003-03-01 This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
NCT00062790 ↗ Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels Completed GlaxoSmithKline Phase 4 2003-10-01 This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
NCT00070733 ↗ The Effect of 5-Alpha Reductase on Testosterone in Men Unknown status Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2003-08-01 The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle strength, and sexual function in men. This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dutasteride

Condition Name

Condition Name for Dutasteride
Intervention Trials
Prostate Cancer 25
Prostatic Hyperplasia 22
Benign Prostatic Hyperplasia 20
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Condition MeSH

Condition MeSH for Dutasteride
Intervention Trials
Prostatic Hyperplasia 45
Hyperplasia 43
Prostatic Neoplasms 32
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Clinical Trial Locations for Dutasteride

Trials by Country

Trials by Country for Dutasteride
Location Trials
United States 236
Germany 69
United Kingdom 51
Canada 35
Italy 31
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Trials by US State

Trials by US State for Dutasteride
Location Trials
Washington 16
Massachusetts 14
Maryland 12
California 10
Illinois 10
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Clinical Trial Progress for Dutasteride

Clinical Trial Phase

Clinical Trial Phase for Dutasteride
Clinical Trial Phase Trials
Phase 4 19
Phase 3 20
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Dutasteride
Clinical Trial Phase Trials
Completed 83
Unknown status 7
Terminated 6
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Clinical Trial Sponsors for Dutasteride

Sponsor Name

Sponsor Name for Dutasteride
Sponsor Trials
GlaxoSmithKline 58
University of Washington 7
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 5
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Sponsor Type

Sponsor Type for Dutasteride
Sponsor Trials
Other 85
Industry 75
NIH 19
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