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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 22, 2008

Start Date ^ICMJE

September 2005

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

hair density after 3, 6 and 9 months

Change History

Complete list of historical versions of study NCT00175617 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

1) percentage of subjects who experience side effects
2) subject assessment of treatment effect

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy of Therapy With the Anti-Androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Female Pattern Hair Loss

Intervention ^ICMJE

Drug: Spironolactone
Drug: Minoxidil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andreas Finner

604 875 4747

andreas.finner@vch.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00175617

Responsible Party

Dr. Jerry Shapiro, University of British Columbia

Study ID Numbers ^ICMJE

C05-0060

Study Sponsor ^ICMJE

University of British Columbia

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jerry Shapiro, MD

University of British Columbia

Information Provided By

University of British Columbia

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP