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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-31

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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Female Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Combination Group

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

Group Type ACTIVE_COMPARATOR

5% Minoxidil

Intervention Type DRUG

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

200mg Spironolactone

Intervention Type DRUG

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

Single Group

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

Group Type ACTIVE_COMPARATOR

5mg Finasteride

Intervention Type DRUG

This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Placebo

Intervention Type OTHER

This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Interventions

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5% Minoxidil

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

Intervention Type DRUG

200mg Spironolactone

This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.

Intervention Type DRUG

5mg Finasteride

This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Intervention Type DRUG

Placebo

This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.

Intervention Type OTHER

Other Intervention Names

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Rogaine® Theroxidil® Minoxidil Topical Aldactone® Propecia® Proscar® placebo topical preparation

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes