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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175617
First received: September 13, 2005
Last updated: November 15, 2011
Last verified: November 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Therapy With the Anti-androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss

Resource links provided by NLM:


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 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Spironolactone
    This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
    Drug: Minoxidil
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175617     History of Changes
Other Study ID Numbers: C05-0060
Study First Received: September 13, 2005
Last Updated: November 15, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases
Androgen Antagonists
Minoxidil
Spironolactone
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014