NCT00175617

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2009

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

3.5 years

First QC Date

September 13, 2005

Last Update Submit

March 1, 2017

Conditions

Female Pattern Hair Loss

Outcome Measures

Primary Outcomes (1)

  • hair density

    after 3, 6 and 9 months

Secondary Outcomes (2)

  • percentage of subjects who experience side effects

  • subject assessment of treatment effect

Interventions

SpironolactoneDRUG

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

MinoxidilDRUG

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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be premenopausal women older than 18 with female pattern hair loss.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Division of Dermatology, Hair Research and Treatment Centre

Vancouver, British Columbia, V6G 1Y6, Canada

Location

MeSH Terms

Interventions

SpironolactoneMinoxidil

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jerry Shapiro, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

March 9, 2009

Study Completion

March 9, 2009

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

CA(1)