The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

University of Florida

Status and phase: Withdrawn; Phase 4

Conditions: Female Androgenetic Alopecia

Treatments: Drug: 200mg Spironolactone; Drug: 5% Minoxidil; Drug: 5mg Finasteride; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02483195

IRB201500433

Details and patient eligibility

About

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).

Full 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)

Sex: Female

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Combination Group

Active Comparator group

Description:

This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.

Treatment:

Drug: 5% Minoxidil

Drug: 200mg Spironolactone

Single Group

Active Comparator group

Description:

This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.

Treatment:

Other: Placebo

Drug: 5mg Finasteride