Female Androgenetic AlopeciaPhase 4NCT02483195
The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
A Phase 4 study testing 5% Minoxidil, 200mg Spironolactone and 5mg Finasteride in people with Female Androgenetic Alopecia, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Androgenetic Alopecia
- What is being tested?
- 5% Minoxidil, 200mg Spironolactone and 5mg Finasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- postmenopausal (>60 years old or with total hysterectomy)
- diagnosed with androgenetic alopecia
- no chemical processing or changes in hair products throughout the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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:
- Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)
- Conditions
- Female Androgenetic Alopecia
- Being tested
- 5% Minoxidil, 200mg Spironolactone, 5mg Finasteride, Placebo
- Keywords
- Hair loss, Post Menopausal
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% MinoxidilDrug
Also called Rogaine®, Theroxidil®, Minoxidil Topical
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
200mg SpironolactoneDrug
Also called Aldactone®
This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
5mg FinasterideDrug
Also called Propecia®, Proscar®
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
PlaceboOther
Also called placebo topical preparation
This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
| Study group | Role | What they receive |
|---|---|---|
| Combination Group | Active comparator | This group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily. Receives: Drug: 5% Minoxidil; Drug: 200mg Spironolactone |
| Single Group | Active comparator | This group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily. Receives: Drug: 5mg Finasteride; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change at 0, 4, 8, and 12 months
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
Measured: Change at 0, 4, 8, and 12 months
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
Measured: Change at 0, 4, 8, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina L. Mitchell, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483195
- Sponsor's protocol ID
- IRB201500433
- Status last verified
- Aug 2016
- First submitted
- 24 Jun 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT02483195
- Acronym / sponsor ID
- IRB201500433
- Conditions
- Female Androgenetic Alopecia
- Keywords
- Hair loss, Post Menopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI indicating she was withdrawing her study submission due to lack of funding as of 6/20/2016
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Combination 5% Minoxidil and 200mg Spironolactone (Combination Group) B) 5mg Finasteride with placebo topical preparation (Single Group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Group | Active comparator | Drug: 5% Minoxidil, Drug: 200mg SpironolactoneThis group will use a mixed combination of 5% Minoxidil and 200mg Spironolactone for 12 months to be used once daily. |
| Single Group | Active comparator | Drug: 5mg Finasteride, Other: PlaceboThis group will use a mixed combination of 5mg Finasteride with placebo topical preparation for 12 months to be used once daily. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female
- postmenopausal (>60 years old or with total hysterectomy)
- diagnosed with androgenetic alopecia
- no chemical processing or changes in hair products throughout the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% MinoxidilAlso: Rogaine®, Theroxidil®, Minoxidil TopicalThis will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily. | Drug | Combination Group |
| 200mg SpironolactoneAlso: Aldactone®This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily. | Drug | Combination Group |
| 5mg FinasterideAlso: Propecia®, Proscar®This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily. | Drug | Single Group |
| PlaceboAlso: placebo topical preparationThis will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily. | Other | Single Group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L. Mitchell, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5% Minoxidil, 200mg Spironolactone and 5mg Finasteride in people with Female Androgenetic Alopecia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.