Clinical trial NCT02483195: The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Official title: The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Female Androgenetic Alopecia
Keywords: Hair loss
Post Menopausal
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to conduct a head-to-head, randomized clinical trial to compare the effectiveness of Minoxidil with Spironolactone and Finasteride in treating postmenopausal females with Androgenetic Alopecia (AGA).

Detailed description: Participants diagnosed with AGA will be randomized into one of the two treatment arms outlined below, and will take the assigned treatment for a total duration of 12 months. Medications will be dispensed by a nurse who is blinded to the participants within each treatment group. Global photograph assessment and participant questionnaires at 0, 4, 8 and 12 months will be the primary means to determine improvement in hair loss.

Compare the following interventions in treating postmenopausal female AGA:

A) Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)

Eligibility criteria: Inclusion Criteria:

* female
* postmenopausal (\>60 years old or with total hysterectomy)
* diagnosed with androgenetic alopecia
* no chemical processing or changes in hair products throughout the study

Exclusion Criteria:

* men
* premenopausal women (\<60 or without hysterectomy)
* participants allergic to any of the study medications (minoxidil, finasteride, spironolactone)
* participants with other co-existing forms of alopecia (traction, alopecia areata, or scarring alopecias)
* participants with obstructive uropathy or advanced liver disease
* prior hair loss treatment within the last 6 months
* hair loss from the chemotherapy or other medication-induced alopecia
* Hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a period.

Primary outcomes:
measure: The Savin Scale will be used to determine hair growth and/or hair loss between the groups.
timeFrame: Change at 0, 4, 8, and 12 months
measure: The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.
timeFrame: Change at 0, 4, 8, and 12 months
measure: Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
timeFrame: Change at 0, 4, 8, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Christina L. Mitchell, M.D.
role: PRINCIPAL_INVESTIGATOR
References: