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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.
Androgenetic alopecia is a common, androgen-induced, pattern of progressive loss of scalp hair with an onset at any age after puberty in genetically predisposed people. The influence of androgens on scalp hair growth is mediated by local and systemic conversion of testosterone to dihydrotestosterone , by the enzyme 5 alpha-reductase. 5 alpha-reductase has been shown to exist as 2 isoenzyme forms, Type 1 and Type 2. Type 1 is predominantly located in the skin, both in the hair follicles and sebaceous glands, and is also found in the liver and kidney . Type 2 is the dominant form in male genitalia, including the prostate, although it has also been reported to be present in the inner root sheath of the hair follicle. The presence of both isoenzymes in the hair follicles suggests that both forms are likely to be important in the pathogenesis and treatment of androgenetic alopecia. Inhibition of both Type 1 and Type 2 5 alpha-reductase may be expected to more effectively reduce systemic and local dihydrotestosterone levels than inhibition of either isoenzyme alone.
Finasteride is a selective Type 2 5 alpha-reductase inhibitor that is currently the only approved oral treatment for androgenetic alopecia worldwide. Dutasteride inhibits both Type 1 and Type 2 5alpha-reductase and is approved in more than 80 countries for the treatment of benign prostatic hyperplasia, and in Korea for the treatment of hair loss. Dutasteride is approximately 3 times as potent as finasteride at inhibiting Type 2 5 alpha-reductase and more than 100 times as potent at inhibiting Type 1 5 alpha-reductase.
In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mg Finasteride | Active Comparator | 1mg finasteride active plus dutasteride placebo, by mouth once daily |
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| 0.02mg Dutasteride | Active Comparator | 0.02mg dutasteride active plus finasteride placebo, by mouth once daily |
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| 0.1mg Dutasteride | Active Comparator | 0.1mg dutasteride active plus finasteride placebo, by mouth once daily |
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| 0.5mg Dutasteride | Active Comparator | 0.5mg dutasteride active plus finasteride placebo, by mouth once daily |
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| Placebo | Placebo Comparator | 1mg finasteride placebo plus dutasteride placebo, by mouth once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1mg Finasteride active | Drug | 1mg finasteride active, by mouth once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | CABA | Buenos Aires | C1055AAO | Argentina | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114263 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dutasteride 0.02 mg | Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily |
| FG001 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 0.02mg dutasteride |
| Drug |
0.02mg dutasteride active, by mouth once daily |
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| 0.1mg dutasteride | Drug | 0.1mg dutasteride active, by mouth once daily |
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| 0.5mg dutasteride | Drug | 0.5mg dutasteride active, by mouth once daily |
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| Finasteride placebo | Drug | finasteride placebo, by mouth once daily |
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| Dutasteride placebo | Drug | dutasteride placebo, by mouth once daily |
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| Baseline and Week 24 |
| 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 | 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. | Baseline and Week 12 |
| 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 | 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. | Baseline and Week 12 |
| 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 | 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. | Baseline, Week 12, and Week 24 |
| 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 | 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. | Baseline, Week 12, and Week 24 |
| 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 | 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. | Baseline, Week 12, and Week 24 |
| 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 | 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. | Baseline, Week 12, and Week 24 |
| Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately | 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. | Baseline and Week 24 |
| Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately | 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. | Baseline and Week 12 |
| Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately | 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. | Baseline and Week 24 |
| Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12) | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | Baseline and Week 12 |
| Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24 | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | Baseline and Week 24 |
| Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | Week 12, Week 24, and Week 26 |
| Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | Week 12, Week 24, and Week 26 |
| Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24 | Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: "Since the start of treatment, when I look at my thinning area, I can see...", "Since the start of treatment, my hair now covers…", and "Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is…" -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9). | Baseline, Week 12, and Week 24 |
| Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24 | Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15). | Baseline, Week 12, and Week 24 |
| Ciudad Autonoma de Buenos Aires |
| Buenos Aires |
| C1425BEA |
| Argentina |
| GSK Investigational Site | La Boca | Buenos Aires | C1155AHD | Argentina |
| GSK Investigational Site | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Buenos Aires | C1114AAP | Argentina |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7580206 | Chile |
| GSK Investigational Site | Viña del Mar | Valparaiso | 252 0000 | Chile |
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
| GSK Investigational Site | Osaka | 530-0057 | Japan |
| GSK Investigational Site | Osaka | 532-0003 | Japan |
| GSK Investigational Site | Tokyo | 103-0028 | Japan |
| GSK Investigational Site | Tokyo | 160-0022 | Japan |
| GSK Investigational Site | Zapopan, Jalisco | Jalisco | 45190 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| GSK Investigational Site | Mazatlan, Sinaloa | Sinaloa | 82126 | Mexico |
| GSK Investigational Site | Naucalpan | State of Mexico | 11200 | Mexico |
| GSK Investigational Site | Mexico City | 03720 | Mexico |
| GSK Investigational Site | Mexico City | 06780 | Mexico |
| GSK Investigational Site | Lima | Lima Province | Lima 41 | Peru |
| GSK Investigational Site | Lima | Lima 27 | Peru |
| GSK Investigational Site | Lima Cercado | LIMA 01 | Peru |
| GSK Investigational Site | Makati City | 1200 | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Quezon City | 1113 | Philippines |
| GSK Investigational Site | Quezon City | Philippines |
| GSK Investigational Site | Tanauan City, Batangas | 4232 | Philippines |
| GSK Investigational Site | Moscow | 107076 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603950 | Russia |
| GSK Investigational Site | Ryazan | 390046 | Russia |
| GSK Investigational Site | Saint Petersburg | 196084 | Russia |
| GSK Investigational Site | St'Petersburg | 192102 | Russia |
| GSK Investigational Site | Tainan | 70403 | Taiwan |
| GSK Investigational Site | Taipei | 105 | Taiwan |
| GSK Investigational Site | Taipei | 220 | Taiwan |
| GSK Investigational Site | Taipei | Taiwan |
| GSK Investigational Site | Bangkoknoi Bangkok | 10700 | Thailand |
| GSK Investigational Site | Chiang Mai | 50200 | Thailand |
| GSK Investigational Site | Patumwan Bangkok | 10330 | Thailand |
| GSK Investigational Site | Rajthevee Bangkok | 10400 | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114263 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG002 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily |
| FG003 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily |
| FG004 | Placebo | Matching dutasteride placebo and finasteride placebo once daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dutasteride 0.02 mg | Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily |
| BG001 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily |
| BG002 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily |
| BG003 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily |
| BG004 | Placebo | Matching dutasteride placebo and finasteride placebo once daily |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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) | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline and Week 24 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline and Week 24 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline and Week 12 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline and Week 12 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | millimeters | Baseline, Week 12, and Week 24 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | millimeters | Baseline, Week 12, and Week 24 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline, Week 12, and Week 24 |
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| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Hair count | Baseline, Week 12, and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately | 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. | 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. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately | 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. | 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. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately | 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. | 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. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12) | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | 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. The number of participants analyzed reflects the sum of the participants with the three BL stages. | Posted | Number | participants | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24 | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | 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. The number of participants analyzed reflects the sum of the participants with the three BL stages. | Posted | Number | participants | Baseline and Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | ITT Population. All participants for whom data were collected at Baseline, Week 12, and Week 24 were assessed. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Week 12, Week 24, and Week 26 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | 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. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | Week 12, Week 24, and Week 26 |
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| Secondary | Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24 | Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: "Since the start of treatment, when I look at my thinning area, I can see...", "Since the start of treatment, my hair now covers…", and "Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is…" -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9). | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 12, and Week 24 |
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| Secondary | Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24 | Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15). | ITT Population. Calculation was based on the LOCF imputation method for missing data. All participants for whom data were collected at Week 12 and Week 24 were assessed. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Week 12, and Week 24 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dutasteride 0.02 mg | Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily | 0 | 185 | 34 | 185 | ||
| EG001 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily | 3 | 188 | 34 | 188 | ||
| EG002 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily | 1 | 184 | 41 | 184 | ||
| EG003 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily | 2 | 179 | 32 | 179 | ||
| EG004 | Placebo | Matching dutasteride placebo and finasteride placebo once daily | 2 | 181 | 36 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Cartilage injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fractured sacrum | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Infection parasitic | Infections and infestations | Systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Systematic Assessment |
| ||
| Lower limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Pharyngeal abscess | Infections and infestations | Systematic Assessment |
| ||
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Salmonellosis | Infections and infestations | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Libido decreased | Psychiatric disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| American Indian or Alaskan Native |
|
| African American/African Heritage |
|
| Asian - South East Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - Mixed Race |
|
| White - White/Caucasian/European Heritage |
|
| General linear model |
| <0.001 |
| LS mean difference |
| 67.9 |
| 2-Sided |
| 98.33 |
| 41.6 |
| 94.2 |
Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean. |
| Superiority or Other |
| General linear model | Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model. | <0.001 | LS mean difference | 94.4 | 2-Sided | 98.33 | 67.8 | 121.0 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean. | Superiority or Other |
| General linear model | <0.001 | Least squares mean difference | 61.4 | 2-Sided | 98.33 | 34.4 | 88.4 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean. | Superiority or Other |
| General linear model | <0.001 | Least squares mean difference | -39.4 | 99.165 | -66.1 | -12.7 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean. | Non-Inferiority or Equivalence | Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC. |
| General linear model | 0.28 | Least squares mean difference | 6.5 | 99.165 | -20.1 | 33.1 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean. | Non-Inferiority or Equivalence | Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC. |
| General linear model | 0.002 | Least squares mean difference | 33 | 99.165 | 6.1 | 60 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean. | Non-Inferiority or Equivalence | Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC. |
| General linear model | <0.001 | Least squares mean difference | -39.4 | 2-Sided | 98.33 | -66.1 | -12.7 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean. | Superiority or Other |
| General linear model | 0.56 | Least squares mean difference | 6.5 | 2-Sided | 98.33 | -20.1 | 33.1 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean. | Superiority or Other |
| General linear model | 0.003 | Least squares mean difference | 33 | 2-Sided | 98.33 | 6.1 | 60 | Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean. | Superiority or Other |
| OG002 |
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 |
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 |
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 |
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| OG002 | Dutasteride 0.1 mg | Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Dutasteride 0.5 mg |
Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|
| Dutasteride 0.1 mg |
Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG003 | Dutasteride 0.5 mg | Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food. |
| OG004 | Finasteride 1 mg | Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food. |
|
|