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Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

NCT01231607 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 917

Last updated 2018-08-10

Study results available
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Summary

The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.

Conditions

Interventions

DRUG

1mg Finasteride active

1mg finasteride active, by mouth once daily

DRUG

0.02mg dutasteride

0.02mg dutasteride active, by mouth once daily

DRUG

0.1mg dutasteride

0.1mg dutasteride active, by mouth once daily

DRUG

0.5mg dutasteride

0.5mg dutasteride active, by mouth once daily

DRUG

Finasteride placebo

finasteride placebo, by mouth once daily

DRUG

Dutasteride placebo

dutasteride placebo, by mouth once daily

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-28
Primary Completion
2012-02-01
Completion
2012-02-28

Countries

  • Argentina
  • Chile
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Russia
  • Taiwan
  • Thailand

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01231607 on ClinicalTrials.gov