Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01231607 |
Recruitment Status :
Completed
First Posted : November 1, 2010
Results First Posted : October 4, 2012
Last Update Posted : August 10, 2018
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Androgenetic Alopecia |
Interventions |
Drug: 1mg Finasteride active Drug: 0.02mg dutasteride Drug: 0.1mg dutasteride Drug: 0.5mg dutasteride Drug: Finasteride placebo Drug: Dutasteride placebo |
Enrollment | 917 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dutasteride 0.02 mg | Dutasteride 0.1 mg | Dutasteride 0.5 mg | Finasteride 1 mg | Placebo |
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Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily | Dutasteride 0.1 mg and finasteride placebo once daily | Dutasteride 0.5 mg and finasteride placebo once daily | Finasteride 1 mg and dutasteride placebo once daily | Matching dutasteride placebo and finasteride placebo once daily |
Period Title: Overall Study | |||||
Started | 185 | 188 | 184 | 179 | 181 |
Completed | 156 | 154 | 153 | 141 | 157 |
Not Completed | 29 | 34 | 31 | 38 | 24 |
Reason Not Completed | |||||
Adverse Event | 0 | 8 | 4 | 4 | 5 |
Lost to Follow-up | 13 | 11 | 10 | 10 | 4 |
Physician Decision | 4 | 4 | 3 | 5 | 4 |
Protocol Violation | 3 | 2 | 0 | 2 | 2 |
Withdrawal by Subject | 9 | 9 | 14 | 17 | 9 |
Baseline Characteristics
Arm/Group Title | Dutasteride 0.02 mg | Dutasteride 0.1 mg | Dutasteride 0.5 mg | Finasteride 1 mg | Placebo | Total | |
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Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily | Dutasteride 0.1 mg and finasteride placebo once daily | Dutasteride 0.5 mg and finasteride placebo once daily | Finasteride 1 mg and dutasteride placebo once daily | Matching dutasteride placebo and finasteride placebo once daily | Total of all reporting groups | |
Overall Number of Baseline Participants | 185 | 188 | 184 | 179 | 181 | 917 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 185 participants | 188 participants | 184 participants | 179 participants | 181 participants | 917 participants | |
38.5 (7.72) | 38.7 (7.44) | 38.6 (7.66) | 38.0 (7.81) | 38.7 (8.43) | 38.5 (7.80) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 185 participants | 188 participants | 184 participants | 179 participants | 181 participants | 917 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Male |
185 100.0%
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188 100.0%
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184 100.0%
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179 100.0%
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181 100.0%
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917 100.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 185 participants | 188 participants | 184 participants | 179 participants | 181 participants | 917 participants |
Asian - Japanese Heritage | 40 | 40 | 40 | 40 | 39 | 199 | |
American Indian or Alaskan Native | 37 | 38 | 39 | 36 | 38 | 188 | |
African American/African Heritage | 1 | 0 | 0 | 0 | 1 | 2 | |
Asian - South East Asian Heritage | 44 | 43 | 42 | 41 | 41 | 211 | |
Asian - East Asian Heritage | 19 | 20 | 19 | 19 | 19 | 96 | |
Asian - Mixed Race | 0 | 0 | 0 | 0 | 1 | 1 | |
White - White/Caucasian/European Heritage | 44 | 47 | 44 | 43 | 42 | 220 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01231607 |
Other Study ID Numbers: |
114263 |
First Submitted: | October 28, 2010 |
First Posted: | November 1, 2010 |
Results First Submitted: | August 30, 2012 |
Results First Posted: | October 4, 2012 |
Last Update Posted: | August 10, 2018 |