The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02483195 |
Recruitment Status :
Withdrawn
(PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016)
First Posted : June 26, 2015
Last Update Posted : September 2, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Androgenetic Alopecia | Drug: 5% Minoxidil Drug: 200mg Spironolactone Drug: 5mg Finasteride Other: Placebo | Phase 4 |
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)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia |
Study Start Date : | August 2016 |
Estimated Primary Completion Date : | August 2018 |
Estimated Study Completion Date : | August 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Combination Group
This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily.
|
Drug: 5% Minoxidil
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
Other Names:
Drug: 200mg Spironolactone This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
Other Name: Aldactone® |
Active Comparator: Single Group
This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily.
|
Drug: 5mg Finasteride
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
Other Names:
Other: Placebo This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
Other Name: placebo topical preparation |
- The Savin Scale will be used to determine hair growth and/or hair loss between the groups. [ Time Frame: 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.
- The Ludwig Scale will be used to determine hair growth and/or hair loss between the groups. [ Time Frame: 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
- Alopecia improvement assessment will be used to determine hair growth and/or hair loss between the groups. [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483195
United States, Florida | |
UF Health | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Christina L. Mitchell, M.D. | University of Florida |
Responsible Party: | University of Florida |
ClinicalTrials.gov Identifier: | NCT02483195 |
Other Study ID Numbers: |
IRB201500433 |
First Posted: | June 26, 2015 Key Record Dates |
Last Update Posted: | September 2, 2016 |
Last Verified: | August 2016 |
Hair loss Post Menopausal |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases Pathological Conditions, Anatomical Minoxidil Spironolactone Finasteride Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Antihypertensive Agents Vasodilator Agents 5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |