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

Phase 4

Withdrawn

Interventions: Drug: 5% Minoxidil
Drug: 5mg Finasteride
Drug: 200mg Spironolactone
Other: Placebo

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)

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Combination Group	5% Minoxidil	This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
Single Group	5mg Finasteride	This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.
Combination Group	200mg Spironolactone	This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
Single Group	Placebo	This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.

Primary Outcome Measures

Name	Time	Method
Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.	Change at 0, 4, 8, and 12 months	The value will be one of 7 numbers, ranging from -3 to +3. The values will stand for the following: * 3: markedly worsened alopecia * 2: moderately worsened alopecia * 1: slightly worsened alopecia 0: no change in alopecia * 1: slightly improved alopecia * 2: moderately improved alopecia * 3: markedly improved alopecia
The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.	Change at 0, 4, 8, and 12 months	This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3
The Savin Scale will be used to determine hair growth and/or hair loss between the groups.	Change at 0, 4, 8, and 12 months	This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia.

Secondary Outcome Measures

Name	Time	Method

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