Trial · NCT00441116
A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia
NCT00441116, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia. Trials, record NCT00441116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00441116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia
- NCT number
- NCT00441116
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 153 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alopecia
- Interventions
- Dutasteride 0.5mg oral tablets
- First posted
- 2007-02-28
- Last updated
- 2018-08-16
- Results first posted
- 2009-04-22
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Baseline and 6 months | The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software. |
| Secondary | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Baseline and Month 3 | The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index without Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions without photographs concerning their perception of Change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Month 3 and Month 6 | GlaxoSmithKline - Hair Growth Index with Photographs subject assessment of change in hair loss and overall appearance at 3 and 6 months. Subjects answered 4 questions comparing photographs of their hair before treatment and concerning the last week and evaluated the change in Hair Growth. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Baseline and 6 months | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint. | hair count per centimeters squared | MEAN |
| SECONDARY | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Baseline and Month 3 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint. | hair count per centimeters squared | MEAN |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study medication and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since Start of Treatment the Overall Appearance (Thickness, Hair Quality, Amount) of the Hair on my Head is? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
| SECONDARY | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Appearance (Thickness, Hair Quality, Amount) of the Thinning Area on my Head is? | Month 3 and Month 6 | Intent to Treat (ITT) population defined as all randomized subjects received at least one dose of study mediction and having at least one on visit endpoint. | Participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group890
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Dutasteride | Baseline | 148.14 | Standard Deviation 36.27 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Placebo | Baseline | 144.27 | Standard Deviation 32.33 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Dutasteride | Month 6 | 162.27 | Standard Deviation 38.52 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Placebo | Month 6 | 149.57 | Standard Deviation 34.44 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Dutasteride | Change from Baseline - Month 6 | 12.21 | Standard Deviation 23.60 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. | Placebo | Change from Baseline - Month 6 | 4.67 | Standard Deviation 16.81 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Dutasteride | Baseline | 148.14 | Standard Deviation 36.27 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Placebo | Baseline | 144.27 | Standard Deviation 32.33 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Dutasteride | Month 3 | 160.19 | Standard Deviation 36.73 | hair count per centimeters squared |
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months. | Placebo | Month 3 | 154.50 | Standard Deviation 36.87 | hair count per centimeters squared |
1 to 10 of 890Source ClinicalTrials.gov
See all 890 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dutasteride | 76 | |
| Overall Study | STARTED | Placebo | 77 | |
| Overall Study | COMPLETED | Dutasteride | 73 | |
| Overall Study | COMPLETED | Placebo | 75 | |
| Overall Study | NOT COMPLETED | Dutasteride | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Dutasteride | 12 | 73 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Placebo | 7 | 75 | |
| serious | Thyroid Cancer | Endocrine disorders | Dutasteride | 0 | 73 | 0 |
| serious | Thyroid Cancer | Endocrine disorders | Placebo | 1 | 75 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dutasteride | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dutasteride | 12 | 73 |
| Total, other adverse events | Placebo | 7 | 75 |
| Total, serious adverse events | Dutasteride | 0 | |
| Total, serious adverse events | Placebo | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00441116
GET https://conductscience.org/api/trials/v1/NCT00441116/registered?page=2