AlopeciaPhase 3NCT00441116

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

A Phase 3 study testing Dutasteride 0.5mg oral tablets in people with Alopecia, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 49 years, men only
Conditions the study is for: Alopecia
What is being tested?: Dutasteride 0.5mg oral tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 153 participants
Where: No sites listed yet
Study dates: 15 Dec 2006to 21 Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Men only
No healthy volunteers
Adult

Who may be able to join

Rationale - The vertex area of the scalp will be evaluated during this study, therefore the inclusion criterion of Norwood Hamilton areas IIIv, IV or V ensures that subjects with vertex hair loss will be recruited in line with the primary efficacy endpoint of change in hair growth in the vertex.
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Male out-patients aged 18-49 years, inclusive
Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (Figure 1) (N.B. types IVa and Va are excluded)
Able to comprehend instructions and record required information
Will provide signed and dated written informed consent to participate in this investigation

Who cannot join

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.

Show all 29Show fewer

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:
Minoxidil (oral or topical)
Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
Topical estrogen, progesterone
Tamoxifen
Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)
Anabolic steroids
Lithium and phenothiazines
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.

About this study

Official title: An Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Dutasteride 0.5mg Once Daily for 6 Months in the Treatment of Male Subjects With Androgenetic Alopecia (Norwood-Hamilton Classification Type IIIv, IV and V)

Conditions: Alopecia
Being tested: Dutasteride 0.5mg oral tablets
Keywords: dutasteride, Androgenic alopecia, phase 3
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dutasteride 0.5mg oral tabletsDrug
Dutasteride

Study groups in NCT00441116
Study group	Role	What they receive
Dutasteride	Placebo comparator	Dutasteride Receives: Drug: Dutasteride 0.5mg oral tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 6 months

Secondary outcomes (30)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 6 and Month 10
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Sodium, Potassium (mEq/L), and Bicarbonate
Measured: Baseline and Month 6
Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Comparing Lab values and differences from Baseline to month 6
Measured: 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)
Measured: Baseline and Month 6
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Glucose, Creatinine, Ferritine (ug/L) and Zinc (Hmol/L)
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 200621 Jan 2008

First posted28 Feb 2007 (estimated)
Study start15 Dec 2006
Primary completion21 Jan 2008
Study completion21 Jan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AlopeciaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441116
Sponsor's protocol ID: 106377
Status last verified: Jul 2018
First submitted: 27 Feb 2007
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
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All Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Dutasteride 0.5mg Once Daily for 6 Months in the Treatment of Male Subjects With Androgenetic Alopecia (Norwood-Hamilton Classification Type IIIv, IV and V)
ClinicalTrials.gov ID: NCT00441116
Acronym / sponsor ID: 106377
Conditions: Alopecia
Keywords: dutasteride, Androgenic alopecia, phase 3
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Dec 2006 (actual)
Primary completion: 21 Jan 2008 (actual)
Study completion: 21 Jan 2008 (actual)
First posted: 28 Feb 2007 (estimated)
Results: Posted 22 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
Dutasteride	Placebo comparator	Drug: Dutasteride 0.5mg oral tabletsDutasteride

Who may qualify

Ages: 18 to 49 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Rationale - The vertex area of the scalp will be evaluated during this study, therefore the inclusion criterion of Norwood Hamilton areas IIIv, IV or V ensures that subjects with vertex hair loss will be recruited in line with the primary efficacy endpoint of change in hair growth in the vertex.
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Male out-patients aged 18-49 years, inclusive
Diagnosis of Male Pattern Hair Loss classified as type IIIv, IV, or V utilising the modified Norwood-Hamilton classification (Figure 1) (N.B. types IVa and Va are excluded)
Able to comprehend instructions and record required information

Key exclusion criteria (29 listed)

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dutasteride 0.5mg oral tabletsDutasteride	Drug	Dutasteride

Primary outcome

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.
Time frame: Baseline and 6 months
The Macrophotographic hair count method marks a 1-inch diameter circular area at the anterior leading edge of the vertex thinning area and then photographed. The photographs are enlarged and converted into dot maps and the dot maps are converted into total hair counts by means of personal computer-based scanners and imaging software.

30 secondary outcomes

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 3 Months.
Time frame: Baseline and Month 3
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Lost?
Time frame: Month 3 and Month 6
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Usual Hair Loss Has Slowed Down?
Time frame: 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?
Time frame: Month 3 and Month 6
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment I Have Kept What Hair I Had?
Time frame: 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?
Time frame: Month 3 and Month 6
Subjects Global Assessment of Hair Regrowth Question: Since the Start of Treatment my Hair Now Covers?
Time frame: 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?
Time frame: 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?
Time frame: Month 3 and Month 6
Investigator's Photographic Assessment of Improvement Distribution From Baseline
Time frame: Month 3 and Month 6
Investigator's Photographic Assessment of Improvements From Baseline Score
Time frame: Month 3 and Month 6
Panel Assessment of Improvement Distribution From Screening
Time frame: Baseline to Month 3 and Baseline to Month 6
The Percentage Change From Baseline in Dihydrotestosterone (DHT) at Month 3, 6, and 10
Time frame: Month 3, Month 6 and Month 10
The Percentage Change From Baseline in Testosterone at Month 3, 6, and 10
Time frame: 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.
Time frame: Baseline to Month 6 and Month 10
Laboratory Values: Electrolytes Assessed at Baseline and 6 Months.
Time frame: Baseline and Month 6
Laboratory Values: Hematology Assessed at Baseline and 6 Months.
Time frame: Baseline and Month 6
Laboratory Values: Liver Enzymes Assessed at Baseline and 6 Months.
Time frame: Baseline and Month 6
Laboratory Values: Other Chemistry Assessed at Baseline and 6 Months.
Time frame: Baseline and Month 6
Sexual Function Inventory - Screening - Sex Drive, Erection, and Ejaculation
Time frame: Screening
Sexual Function Inventory - Baseline - Sex Drive, Erection, and Ejaculation
Time frame: Baseline
Sexual Function Inventory - Month 3 - Sex Drive, Erection, and Ejaculation
Time frame: Month 3
Sexual Function Inventory - Month 6 - Sex Drive, Erection, and Ejaculation
Time frame: Month 6
Sexual Function Inventory - Month 10 - Sex Drive, Erection, and Ejaculation
Time frame: Month 10
Sexual Function Inventory: Shifts From Baseline to Month 6 in Sex Drive
Time frame: Baseline to Month 6
Sexual Function Inventory: Shifts From Baseline to Month 6 - Erection
Time frame: Baseline to Month 6
Sexual Function Inventory: Shifts From Baseline to Month 6 - Ejaculation
Time frame: Baseline to Month 6
Sexual Function Inventory: Shifts From Baseline to Month 10 in Sex Drive
Time frame: Baseline to Month 10
Sexual Function Inventory: Shifts From Baseline to Month 10 - Erection
Time frame: Baseline to Month 10
Sexual Function Inventory: Shifts From Baseline to Month 10 - Ejaculation
Time frame: Baseline to Month 10

Results and safety

Results posted to the registry on 22 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dutasteride	76	73
Placebo	77	75

Primary outcome: Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: hair count per centimeters squared

Measure	Dutasteride n = 73	Placebo n = 75
Baseline	148.14 (36.27)	144.27 (32.33)
Month 6	162.27 (38.52)	149.57 (34.44)
Change from Baseline - Month 6	12.21 (23.60)	4.67 (16.81)

Dutasteride vs Placebo: Median Difference (Final Values): 7.54 (95% CI 0.75 to 14.33), p = 0.0319, t-test, 2 sided

Population analysed: 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.

30 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dutasteride	0 of ?	12 of 73 (16.4%)	Not reported
Placebo	1 of ?	7 of 75 (9.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Alopecia

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
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Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dutasteride 0.5mg oral tablets in people with Alopecia, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00441116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.