Back to resultsEfficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
Primary Purpose
Female Pattern Hair Loss
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Spironolactone
Minoxidil
Sponsored by
About this trial
This is an interventional treatment trial for Female Pattern Hair Loss
Eligibility Criteria
Inclusion Criteria: Subjects must be premenopausal women older than 18 with female pattern hair loss. Exclusion Criteria: Androgen excess Other scalp or hair disorders Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats
Sites / Locations
- UBC Division of Dermatology, Hair Research and Treatment Centre
Outcomes
Primary Outcome Measures
hair density
Secondary Outcome Measures
percentage of subjects who experience side effects
subject assessment of treatment effect
Full Information
NCT ID
NCT00175617
First Posted
September 13, 2005
Last Updated
March 1, 2017
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00175617
Brief Title
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
Official Title
Efficacy of Therapy With the Anti-androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 9, 2009 (Actual)
Study Completion Date
March 9, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Hair Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
Intervention Type
Drug
Intervention Name(s)
Minoxidil
Intervention Description
This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
Primary Outcome Measure Information:
Title
hair density
Time Frame
after 3, 6 and 9 months
Secondary Outcome Measure Information:
Title
percentage of subjects who experience side effects
Title
subject assessment of treatment effect
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be premenopausal women older than 18 with female pattern hair loss.
Exclusion Criteria:
Androgen excess
Other scalp or hair disorders
Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs
Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry Shapiro, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Division of Dermatology, Hair Research and Treatment Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6G 1Y6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss
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