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The aim of this Phase III study is to compare the efficacy, safety and tolerability of dutasteride (0.5mg) with placebo for 6 months, in Korean male subjects with androgenetic alopecia in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride | Placebo Comparator | Dutasteride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dutasteride 0.5mg oral tablets | Drug | Dutasteride |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 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. |
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Inclusion criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Evidence of hypogonadism defined as serum testosterone < 250ng/dl and/or LH >20mIU/ml Note: If the initial serum testosterone result is < 250ng/dl and the LH value is normal, the test may be repeated once. Attempts should be made, where possible, to collect all samples in the morning hours. If the repeat testosterone result is < 250ng/dl, the subject is not eligible for participation.
Greater than two times the upper limit of normal for ALT or AST, or a bilirubin greater than 2.0mg/dl (exception - subjects diagnosed with Gilbert's syndrome will be eligible to participate in the study)
Serum creatinine >1.8mg/dl
Global scalp hair thinning, including occipital areas
Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., uncontrolled seborrheic dermatitis, tinea infections, other causes of alopecia, prior hair transplants or scalp reductions, psoriatic dermatitis) and inability to discontinue use of hair weaving.
Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair. Subjects must maintain their natural hair colour throughout the study.
Hair length in non-balding areas ≤2cm (3/4 inch) around the vertex region of the head. Subjects must maintain the same hairstyle throughout the study.
History of malignancy within the past five years, except basal cell or squamous cell carcinoma of the skin
Serum PSA level > 2.0 ng/ml at screening visit.
Family history(Father, brothers) of prostate cancer.
Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for 3 months and serum TSH is normal
Hypersensitivity to any 5 AR inhibitor or drugs chemically related to the study medication
Use of finasteride or other 5 AR inhibitors within the 12 months prior to screening.
Previous use of dutasteride.
Use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to screening.
Previous use of cytotoxic agents
Use of glucocorticoids (inhaled glucocorticoids are allowed; topical steroids are allowed provided that they are not used on the scalp) within the 3 months prior to screening
Use of the following during the 6 months prior to screening:
17. Concurrent or regular use during the 4 weeks prior to screening of topical agents to the scalp (e.g., anti-inflammatories) 18. Participation in any investigational or marketed drug trial within 30 days preceding the screening phase of this study. Participation in any other drug trial during the course of this study including the follow-up period.
19. History or current evidence of drug or alcohol abuse within the 12 months prior screening 20. History of any illness (including psychiatric) which may impair the ability to provide informed consent or comply with study requirements 21. History of any unstable illness or condition that, in the opinion of the investigator, might confound the results or put the subject at risk.
22. Subjects who are known to be HIV positive (status which includes subjects with AIDS) 23. Subjects who will not refrain from donating blood until completing the study follow-up period.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dutasteride | Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. |
| FG001 | Placebo | Subjects who were given no Investigational product. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dutasteride | Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 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. | 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. | Posted | Mean | Standard Deviation | hair count per centimeters squared | Baseline and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dutasteride | Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid Cancer | Endocrine disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| 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 |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Baseline and Month 3 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | 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. | Month 3 and Month 6 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | 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. | Month 3 and Month 6 |
| 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? | 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. | Month 3 and Month 6 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | 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. | Month 3 and Month 6 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | 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. | Month 3 and Month 6 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | 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. | Month 3 and Month 6 |
| Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | 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. | Month 3 and Month 6 |
| 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? | 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. | Month 3 and Month 6 |
| Investigator's Photographic Assessment of Improvement Distribution From Baseline | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. | Month 3 and Month 6 |
| Investigator's Photographic Assessment of Improvements From Baseline Score | Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change. | Month 3 and Month 6 |
| Panel Assessment of Improvement Distribution From Screening | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. | Baseline to Month 3 and Baseline to Month 6 |
| The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value. | Month 3, Month 6 and Month 10 |
| The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml. | Month 3, Month 6, and Month 10 |
| Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L. | Baseline to Month 6 and Month 10 |
| Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium, Potassium (mEq/L), and Bicarbonate | Baseline and Month 6 |
| Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Comparing Lab values and differences from Baseline to month 6 | Baseline and Month 6 |
| Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL) | Baseline and Month 6 |
| Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L) | Baseline and Month 6 |
| Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | Screening |
| Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | Baseline |
| Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | Month 3 |
| Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | Month 6 |
| Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | Month 10 |
| Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 6 |
| Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 6 |
| Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 6 |
| Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 10 |
| Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 10 |
| Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | Baseline to Month 10 |
| Did not meet Eligibility Criteria |
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Subjects who were given no Investigational product. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Placebo | Subjects who were given no Investigational product. |
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| Secondary | Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 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. | 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. | Posted | Mean | Standard Deviation | hair count per centimeters squared | Baseline and Month 3 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| 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? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment, When I Look at my Thinning Area, I Can See? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment the Amount of Hair on my Thinning Area Has? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| 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? | 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. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Investigator's Photographic Assessment of Improvement Distribution From Baseline | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. | 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. | Posted | Number | Participants | Month 3 and Month 6 |
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| Secondary | Investigator's Photographic Assessment of Improvements From Baseline Score | Improvement Distribution Score is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range: -3 = greatly decreased to +3 = greatly increased. 0 = No change. | Per Protocol Population (PP) defined as subjects in the ITT population taking study medication for 6 month and no identified as a major protocol violator. | Posted | Mean | Standard Deviation | units on a scale | Month 3 and Month 6 |
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| Secondary | Panel Assessment of Improvement Distribution From Screening | Improvement Distribution is based on the number of hairs per centimeters squared by macrophotographic conversion hair count. Score Range -3=greatly decreased to +3=greatly increased. 0=No change. | 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. | Posted | Number | Participants | Baseline to Month 3 and Baseline to Month 6 |
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| Secondary | The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10 | Mean percent change from Baseline for DHT. DHT was measured in pg/ml. Change from baseline = Month 3, 6, and 10 values minus baseline value. | 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. | Posted | Mean | Standard Deviation | Percent change | Month 3, Month 6 and Month 10 |
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| Secondary | The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10 | Mean percent change from Baseline for testosterone. Testosterone was measured in ng/ml. | 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. | Posted | Mean | Standard Deviation | Percent change | Month 3, Month 6, and Month 10 |
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| Secondary | Endocrinology Shifts in Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Prostate Specific Antigen (PSA), DHT, Testosterone (T), and Luteinizing Hormone (LH) From Baseline to Month 6 and Month 10. | Normal ranges: TSH, 0.25-3.50 µIU/mL; T4, 4.5-12.0 mg/dL; PSA, ≤4 ng/mL; DHT, males (m): prepuberty, <0.1, adult, 0.25-0.75; females (f): prepuberty, <0.03, premenopausal, 0.05-0.3, menopausal, <0.03 ng/mL; T, m: 2.36-9.96; f: 0.08-0.86 ng/mL; LH, m: 1-8; f: follicular, 4-12; periovulatory, >20; luteal 5-20; postmenopausal, >10 IU/L. | 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. LH was only assessed at baseline. | Posted | Number | Participants | Baseline to Month 6 and Month 10 |
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| Secondary | Laboratory Values: Electrolytes Assessed at Baseline and 6 Months. | Sodium, Potassium (mEq/L), and Bicarbonate | 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. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Month 6 |
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| Secondary | Laboratory Values: Hematology Assessed at Baseline and 6 Months. | Comparing Lab values and differences from Baseline to 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. | Posted | Mean | Standard Deviation | thousands/microliter | Baseline and Month 6 |
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| Secondary | Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months. | sGOT (AST)- serum Glutamic-Oxaloacetic Transaminase, sGPT (ALT) - serum Glutamic-Pyruvic Transaminase, Alkaline Phosphatase, Bilirubin(mg/dL) and Albumin(g/dL) | 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. | Posted | Mean | Standard Deviation | IU/L | Baseline and Month 6 |
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| Secondary | Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months. | Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L) | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Month 6 |
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| Secondary | Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | 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. | Posted | Number | Participants | Screening |
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| Secondary | Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | 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. | Posted | Number | Participants | Baseline |
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| Secondary | Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | 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. | Posted | Number | Participants | Month 3 |
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| Secondary | Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | 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. | Posted | Number | Participants | Month 6 |
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| Secondary | Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? | 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. | Posted | Number | Participants | Month 10 |
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| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 6 |
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|
|
| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 6 |
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|
|
| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 6 |
|
|
|
| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 10 |
|
|
|
| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 10 |
|
|
|
| Secondary | Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation | In the past 7 days, to what extent have you considered: a lack of sex drive to be a problem?, your ability to get and keep erections to be a problem? your ejaculation to be a problem? For example, "No Problem shift to No Problem" indicates that the participant experienced no problem at baseline and no problem at Month 6, respectively. | 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. | Posted | Number | Participants | Baseline to Month 10 |
|
|
|
| 0 |
| 12 |
| 73 |
| EG001 | Placebo | Subjects who were given no Investigational product. | 1 | 7 | 75 |
GSK agreements may vary with individual investigators, but will no prohibit any investigator form 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.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| Change from Baseline - Month 3 |
|
| Slightly less hair (Month 3) |
|
| The same amount of hair (Month 3) |
|
| Slightly more hair (Month 3) |
|
| Moderately more hair (Month 3) |
|
| Much more hair (Month 3) |
|
| Much less hair (Month 6) |
|
| Moderately less hair (Month 6) |
|
| Slightly less hair (Month 6) |
|
| The same amount of hair (Month 6) |
|
| Slightly more hair (Month 6) |
|
| Moderately more hair (Month 6) |
|
| Much more hair (Month 6) |
|
| No opinion either way (month 3) |
|
| I agree (month 3) |
|
| I strongly agree (month 3) |
|
| I strongly disagree (month 6) |
|
| I disagree (month 6) |
|
| No opinion either way (month 6) |
|
| I agree (month 6) |
|
| I strongly agree (month 6) |
|
| Slightly worse (Month 3) |
|
| Not Changed (Month 3) |
|
| Slightly Better (Month 3) |
|
| Moderately Better (Month 3) |
|
| Much Better (Month 3) |
|
| Much worse (Month 6) |
|
| Moderately worse (Month 6) |
|
| Slightly worse (Month 6) |
|
| Not changed (Month 6) |
|
| Slightly Better (Month 6) |
|
| Moderately Better (Month 6) |
|
| Much Better (Month 6) |
|
| No opinion either way (Month 3) |
|
| I agree(Month 3) |
|
| I strongly agree (Month 3) |
|
| I strongly disagree (Month 6) |
|
| I disagree (Month 6) |
|
| No opinion either way (Month 6) |
|
| I agree (Month 6) |
|
| I strongly agree(Month 6) |
|
| Slightly less scalp (month 3) |
|
| The same amount of scalp (month 3) |
|
| Slightly more scalp (month 3) |
|
| Moderately more scalp (month 3) |
|
| Much more scalp (month 3) |
|
| Much less scalp (month 6) |
|
| Moderately less scalp (month 6) |
|
| Slightly less scalp (month 6) |
|
| The same amount of scalp (month 6) |
|
| Slightly more scalp (month 6) |
|
| Moderately more scalp (month 6) |
|
| Much more scalp (month 6) |
|
| Slightly less scalp (Month 3) |
|
| The same amount of scalp (Month 3) |
|
| Slightly more scalp (Month 3) |
|
| Moderately more scalp (Month 3) |
|
| Much more scalp (Month 3) |
|
| Much less scalp (Month 6) |
|
| Moderately less scalp (Month 6) |
|
| Slightly less scalp (Month 6) |
|
| The same amount of scalp (Month 6) |
|
| Slightly more scalp (Month 6) |
|
| Moderately more scalp (Month 6) |
|
| Much more scalp (Month 6) |
|
| Slightly decreased (Month 3) |
|
| Stayed the same (Month 3) |
|
| Slightly increased (Month 3) |
|
| Moderately increased (Month 3) |
|
| Greatly increased (Month 3) |
|
| Greatly decreased (Month 6) |
|
| Moderately decreased (Month 6) |
|
| Slightly decreased (Month 6) |
|
| Stayed the same (Month 6) |
|
| Slightly increased (Month 6) |
|
| Moderately increased (Month 6) |
|
| Greatly increased (Month 6) |
|
| Slightly Worse (Month 3) |
|
| Not Changed (Month 3) |
|
| Slightly Better (Month 3) |
|
| Moderately Better (Month 3) |
|
| Much Better (Month 3) |
|
| Much Worse (Month 6) |
|
| Moderately Worse (Month 6) |
|
| Slightly Worse (Month 6) |
|
| Not Changed (Month 6) |
|
| Slightly Better (Month 6) |
|
| Moderately Better (Month 6) |
|
| Much Better (Month 6) |
|
| Slightly decreased (Month 3) |
|
| No Change (Month 3) |
|
| Slightly increased (Month 3) |
|
| Moderately increased (Month 3) |
|
| Greatly increased (Month 3) |
|
| Greatly decreased (Month 6) |
|
| Moderately decreased (Month 6) |
|
| Slightly decreased (Month 6) |
|
| No Change (Month 6) |
|
| Slightly increased (Month 6) |
|
| Moderately increased (Month 6) |
|
| Greatly increased (Month 6) |
|
| Slightly decreased (Month 3) |
|
| No change (Month 3) |
|
| Slightly increased (Month 3) |
|
| Moderately increased (Month 3) |
|
| Greatly increased (Month 3) |
|
| Greatly decreased (Month 6) |
|
| Moderately decreased (Month 6) |
|
| Slightly decreased (Month 6) |
|
| No Change (Month 6) |
|
| Slightly increased (Month 6) |
|
| Moderately increased (Month 6) |
|
| Greatly increased (Month 6) |
|
| % Change in DHT - Month 10 |
|
| % Change in Testosterone - Month 10 |
|
| TSH - Month 6 - Normal |
|
| TSH - Month 6 - Abnormal |
|
| TSH - Month 10 - Normal |
|
| TSH - Month 10 - Abnormal |
|
| T4 - Baseline - Normal |
|
| T4 - Baseline - Abnormal |
|
| T4 - Month 6 - Normal |
|
| T4 - Month 6 - Abnormal |
|
| T4 - Month 10 - Normal |
|
| T4 - Month 10 - Abnormal |
|
| PSA - Screening - Normal |
|
| PSA - Screening - Abnormal |
|
| PSA - Month 6 - Normal |
|
| PSA - Month 6 - Abnormal |
|
| PSA - Month 10 - Normal |
|
| PSA - Month 10 - Abnormal |
|
| DHT - Screening - Normal |
|
| DHT - Screening - Abnormal |
|
| DHT - Month 6 - Normal |
|
| DHT - Month 6 - Abnormal |
|
| DHT - Month 10 - Normal |
|
| DHT - Month 10 - Abnormal |
|
| Testosterone - Screening - Normal |
|
| Testosterone - Screening - Abnormal |
|
| Testosterone - Month 6 - Normal |
|
| Testosterone - Month 6 - Abnormal |
|
| Testosterone - Month 10 - Normal |
|
| Testosterone - Month 10 - Abnormal |
|
| LH - Baseline - Normal |
|
| LH - Baseline - Abnormal |
|
| Potassium (mEq/L) - Baseline |
|
| Potassium (mEq/L) - Month 6 |
|
| Bicarbonate - Baseline |
|
| Bicarbonate - Month 6 |
|
| Neutrophils - Baseline |
|
| Neutrophils - Month 6 |
|
| Lymphocytes - Baseline |
|
| Lymphocytes - Month 6 |
|
| Monocytes - Baseline |
|
| Monocytes - Month 6 |
|
| Eosinophils - Baseline |
|
| Eosinophils - Month 6 |
|
| Basophils - Baseline |
|
| Basophils - Month 6 |
|
| Platelets - Baseline |
|
| Platelets - Month 6 |
|
| Hemoglobin (%)- Baseline |
|
| Hemoglobin (%) - Month 6 |
|
| MCV (fL)- Baseline |
|
| MCV (fL) - Month 6 |
|
| ALT(SGPT) - Baseline |
|
| ALT(SGPT) - Month 6 |
|
| Alkaline Phosphatase - Baseline |
|
| Alkaline Phosphatase - Month 6 |
|
| Bilirubin (mg/dL) - Baseline |
|
| Bilirubin (mg/dL) - Month 6 |
|
| Albumin (g/dL) - Baseline |
|
| Albumin (g/dL) - Month 6 |
|
| Creatinine - Baseline |
|
| Creatinine - Month 6 |
|
| Ferritine (ug/L) - Baseline |
|
| Ferritine (ug/L) - Month 6 |
|
| Zinc (Hmol/L) - Baseline |
|
| Zinc (Hmol/L) - Month 6 |
|
| Sex Drive - Small Problem |
|
| Sex Drive - Medium Problem |
|
| Sex Drive - Big Problem |
|
| Erection - No Problem |
|
| Erection - Very Small Problem |
|
| Erection - Small Problem |
|
| Erection - Medium Problem |
|
| Erection - Big Problem |
|
| Ejaculation - No Problem |
|
| Ejaculation - Very Small Problem |
|
| Ejaculation - Small Problem |
|
| Ejaculation - Medium Problem |
|
| Ejaculation - Big Problem |
|
| Sex Drive - Small problem |
|
| Sex Drive - Medium problem |
|
| Sex Drive - Big problem |
|
| Erection - No Problem |
|
| Erection - Very small problem |
|
| Erection - Small problem |
|
| Erection - Medium problem |
|
| Erection - Big problem |
|
| Ejaculation - No Problem |
|
| Ejaculation - Very small problem |
|
| Ejaculation - Small problem |
|
| Ejaculation - Medium problem |
|
| Ejaculation - Big problem |
|
| Sex Drive - Small Problem |
|
| Sex Drive - Medium Problem |
|
| Sex Drive - Big Problem |
|
| Erection - No Problem |
|
| Erection - Very Small Problem |
|
| Erection - Small Problem |
|
| Erection - Medium Problem |
|
| Erection - Big Problem |
|
| Ejaculation - No Problem |
|
| Ejaculation - Very Small Problem |
|
| Ejaculation - Small Problem |
|
| Ejaculation - Medium Problem |
|
| Ejaculation - Big Problem |
|
| Sex Drive - Small Problem |
|
| Sex Drive - Medium Problem |
|
| Sex Drive - Big Problem |
|
| Erection - No Problem |
|
| Erection - Very Small Problem |
|
| Erection - Small Problem |
|
| Erection - Medium Problem |
|
| Erection - Big Problem |
|
| Ejaculation - No Problem |
|
| Ejaculation - Very Small Problem |
|
| Ejaculation - Small Problem |
|
| Ejaculation - Medium Problem |
|
| Ejaculation - Big Problem |
|
| Sex Drive - Small Problem |
|
| Sex Drive - Medium Problem |
|
| Sex Drive - Big Problem |
|
| Erection - No Problem |
|
| Erection - Very Small Problem |
|
| Erection - Small Problem |
|
| Erection - Medium Problem |
|
| Erection - Big Problem |
|
| Ejaculation - No Problem |
|
| Ejaculation - Very Small Problem |
|
| Ejaculation - Small Problem |
|
| Ejaculation - Medium Problem |
|
| Ejaculation - Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Problem |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Problem |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Problem |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Problem |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Problem |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|
| No Problem shift to Small Problem |
|
| No Problem shift to Medium Problem |
|
| No Problem shift to Big Problem |
|
| Very Small Problem shift to No Problem |
|
| Very Small Problem shift to Very Small Problem |
|
| Very Small Problem shift to Small Problem |
|
| Very Small Problem shift to Medium Problem |
|
| Very Small Problem shift to Big Problem |
|
| Small Problem shift to No Problem |
|
| Small Problem shift to Very Small Problem |
|
| Small Problem shift to Small Problem |
|
| Small Problem shift to Medium Problem |
|
| Small Problem shift to Big Problem |
|
| Medium Problem shift to No Problem |
|
| Medium Problem shift to Very Small Problem |
|
| Medium Problem shift to Small Problem |
|
| Medium Problem shift to Medium Problem |
|
| Medium Problem shift to Big Problem |
|
| Big Problem shift to No Proble |
|
| Big Problem shift to Very Small Problem |
|
| Big Problem shift to Small Problem |
|
| Big Problem shift to Medium Problem |
|
| Big Problem shift to Big Problem |
|