Trial · NCT01231607
Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
NCT01231607, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia. Trials, record NCT01231607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231607
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
- NCT number
- NCT01231607
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 917 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Androgenetic Alopecia
- Interventions
- 1mg Finasteride active, 0.02mg dutasteride, 0.1mg dutasteride, 0.5mg dutasteride, Finasteride placebo, Dutasteride placebo
- First posted
- 2010-11-01
- Last updated
- 2018-08-10
- Results first posted
- 2012-10-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Baseline and Week 24 | The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value. |
| Secondary | Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Baseline and Week 24 | The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value. |
| Secondary | Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT | Baseline and Week 12 | The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value. |
| Secondary | Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12 | Baseline and Week 12 | The primary target area HC was based on the nonvellus hair (\>=30 micrometers \[μm\] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value. |
| Secondary | Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | The target area hair width was the sum of all nonvellus hairs (\>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value. |
| Secondary | Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | The target area hair width was the sum of all nonvellus hairs (\>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value. |
| Secondary | Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (\>=60 μm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value. |
| Secondary | Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (\>=60 μm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value. |
| Secondary | Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately | Baseline and Week 24 | A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views. |
| Secondary | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately | Baseline and Week 12 | The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Baseline and Week 24 | Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Calculation was based on the last observation carried forward (LOCF) imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Baseline and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT | Baseline and Week 12 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12 | Baseline and Week 12 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed. | millimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed. | millimeters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT | Baseline, Week 12, and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline, Week 12, and Week 24 were assessed. | Hair count | LEAST_SQUARES_MEAN |
| SECONDARY | Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately | Baseline and Week 24 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 24 were assessed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately | Baseline and Week 12 | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at both Baseline and Week 12 were assessed. | scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group434
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Placebo | -4.9 | Standard Error 7.89 | Hair count | |
| Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Dutasteride 0.02 mg | 17.1 | Standard Error 7.74 | Hair count | |
| Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Dutasteride 0.1 mg | 63.0 | Standard Error 7.67 | Hair count | |
| Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Dutasteride 0.5 mg | 89.6 | Standard Error 7.87 | Hair count | |
| Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) | Finasteride 1 mg | 56.5 | Standard Error 8.12 | Hair count | |
| Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Placebo | -0.3 | Standard Error 1.74 | Hair count | |
| Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Dutasteride 0.02 mg | 4.2 | Standard Error 1.71 | Hair count | |
| Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Dutasteride 0.1 mg | 12.4 | Standard Error 1.70 | Hair count | |
| Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Dutasteride 0.5 mg | 18.1 | Standard Error 1.74 | Hair count | |
| Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT | Finasteride 1 mg | 12.1 | Standard Error 1.80 | Hair count |
1 to 10 of 434Source ClinicalTrials.gov
See all 434 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dutasteride 0.02 mg | 185 | |
| Overall Study | STARTED | Dutasteride 0.1 mg | 188 | |
| Overall Study | STARTED | Dutasteride 0.5 mg | 184 | |
| Overall Study | STARTED | Finasteride 1 mg | 179 | |
| Overall Study | STARTED | Placebo | 181 | |
| Overall Study | COMPLETED | Dutasteride 0.02 mg | 156 | |
| Overall Study | COMPLETED | Dutasteride 0.1 mg | 154 | |
| Overall Study | COMPLETED | Dutasteride 0.5 mg | 153 | |
| Overall Study | COMPLETED | Finasteride 1 mg | 141 | |
| Overall Study | COMPLETED | Placebo | 157 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events85
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 | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.02 mg | 8 | 185 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.1 mg | 7 | 188 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.5 mg | 10 | 184 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Finasteride 1 mg | 10 | 179 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Placebo | 7 | 181 | |
| other | Headache | Nervous system disorders | Dutasteride 0.02 mg | 8 | 185 | |
| other | Headache | Nervous system disorders | Dutasteride 0.1 mg | 8 | 188 | |
| other | Headache | Nervous system disorders | Dutasteride 0.5 mg | 11 | 184 | |
| other | Headache | Nervous system disorders | Finasteride 1 mg | 5 | 179 | |
| other | Headache | Nervous system disorders | Placebo | 16 | 181 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dutasteride 0.02 mg | ||
| Total, all-cause mortality | Dutasteride 0.1 mg | ||
| Total, all-cause mortality | Dutasteride 0.5 mg | ||
| Total, all-cause mortality | Finasteride 1 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dutasteride 0.02 mg | 34 | 185 |
| Total, other adverse events | Dutasteride 0.1 mg | 34 | 188 |
| Total, other adverse events | Dutasteride 0.5 mg | 41 | 184 |
| Total, other adverse events | Finasteride 1 mg | 32 | 179 |
| Total, other adverse events | Placebo | 36 | 181 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT01231607
GET https://conductscience.org/api/trials/v1/NCT01231607/results?page=2