NCT01052870

Brief Summary

Previous studies of finasteride treatment in women with hair loss have failed to show positive results, yet, some women have responded anecdotally. Given that polymorphisms of the androgen receptor gene which confer androgen sensitivity impact male response to finasteride therapy, it was hypothesized that the same polymorphism in women may identify the group that will respond. This study is designed to test the impact of finasteride therapy on hair loss in postmenopausal women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2008

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

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 16, 2010

Last Update Submit

January 19, 2010

Conditions

Androgenetic Alopecia

Keywords

pharmacogenomics, androgen receptor gene, androgen sensitivity, CAG repeats, androgenetic alopeciaPharmacogenomics in treatment for androgenetic alopecia in women

Study Arms (2)

androgen receptor gene polymorphism

OTHER

Medication response will be assessed according to androgen receptor genotype

Drug: Finasteride

finasteride

ACTIVE COMPARATOR

medication for treating androgenetic alopecia in women

Drug: Finasteride

Interventions

FinasterideDRUG

Effect of 1 mg finasteride on women with androgenetic alopecia depending on their AR gene polymorphism (androgen sensitivity)

androgen receptor gene polymorphismfinasteride

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women with hair loss

You may not qualify if:

  • pre menopausal,
  • metabolic or medication or non-androgenetic causes of hair loss,
  • diffuse hair loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AlopeciaBulbo-Spinal Atrophy, X-Linked

Interventions

Finasteride

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsMuscular Atrophy, SpinalSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesMotor Neuron DiseaseNeuromuscular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAzasteroidsSteroids, Heterocyclic

Study Officials

  • Sharon A Keene, M.D.

    HairDx, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2010

First Posted

January 20, 2010

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01