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

Primary Purpose

Female Androgenetic Alopecia

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
5% Minoxidil
200mg Spironolactone
5mg Finasteride
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Androgenetic Alopecia focused on measuring Hair loss, Post Menopausal

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combination Group

Single Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Savin Scale will be used to determine hair growth and/or hair loss between the groups.
This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia.
The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.
This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3
Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
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

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
August 31, 2016
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02483195
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Androgenetic Alopecia
Keywords
Hair loss, Post Menopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Group
Arm Type
Active Comparator
Arm Description
This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
Arm Title
Single Group
Arm Type
Active Comparator
Arm Description
This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.
Intervention Type
Drug
Intervention Name(s)
5% Minoxidil
Other Intervention Name(s)
Rogaine®, Theroxidil®, Minoxidil Topical
Intervention Description
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
Intervention Type
Drug
Intervention Name(s)
200mg Spironolactone
Other Intervention Name(s)
Aldactone®
Intervention Description
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
Intervention Type
Drug
Intervention Name(s)
5mg Finasteride
Other Intervention Name(s)
Propecia®, Proscar®
Intervention Description
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo topical preparation
Intervention Description
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
Primary Outcome Measure Information:
Title
The Savin Scale will be used to determine hair growth and/or hair loss between the groups.
Description
This will be based on a photographic scale from D1 to D8. With D1 being minimal disease and D8 being severe alopecia.
Time Frame
Change at 0, 4, 8, and 12 months
Title
The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups.
Description
This scale is based on the hair loss pattern. Ludwig Scale: Left = pattern 1, middle = pattern 2, right = pattern 3
Time Frame
Change at 0, 4, 8, and 12 months
Title
Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups.
Description
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
Time Frame
Change at 0, 4, 8, and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L. Mitchell, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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