Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

This study is currently recruiting participants.

Verified by University of British Columbia, September 2008

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175617

Purpose

This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Condition	Intervention	Phase
Female Pattern Hair Loss	Drug: Spironolactone Drug: Minoxidil	Phase II

MedlinePlus related topics: Hair Diseases and Hair Loss

Drug Information available for: Spironolactone Minoxidil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Therapy With the Anti-Androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

hair density [ Time Frame: after 3, 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

percentage of subjects who experience side effects [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
subject assessment of treatment effect [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175617

Contacts

Contact: Andreas Finner

604 875 4747

andreas.finner@vch.ca

Locations

Canada, British Columbia
UBC Division of Dermatology, Hair Research and Treatment Centre	Recruiting
Vancouver, British Columbia, Canada, V6G 1Y6
Contact: Andreas Finner 604 875 4747
Principal Investigator: Jerry Shapiro, MD

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Jerry Shapiro, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Jerry Shapiro )
Study ID Numbers:	C05-0060
Study First Received:	September 13, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00175617
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Skin Diseases
Minoxidil
Alopecia
Spironolactone

Additional relevant MeSH terms:

Hair Diseases
Hypotrichosis
Vasodilator Agents
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009