Idiopathic HirsutismNCT00564252
Topical Finasteride in the Treatment of Idiopathic Hirsutism
A study testing topical finasteride in people with Idiopathic Hirsutism, run by Iran University of Medical Sciences.
Trial summary
the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment of idiopathic hirsutism Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Idiopathic Hirsutism
- What is being tested?
- topical finasteride
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Oct 2006
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic hirsutism which is defined as normal levels of androgens and normal ovulation
- Normal serum prolactin
Who cannot join
- Pregnancy
- Simultaneous use of other drugs for the treatment of hirsutism
About this study
Official title: The Efficacy of Topical Finasteride in the Treatment of Idiopathic Hirsutism
the purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment of idiopathic hirsutism
- Conditions
- Idiopathic Hirsutism
- Being tested
- topical finasteride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical finasterideDrug
0.2%topical(cream)finasteride twice a day for six months
What is being measured
The primary outcome is the main question the study is designed to answer.
the efficacy of topical finasteride was determined by comparison of Ferriman-Gallwey score before and after medication
Measured: 6 months
Secondary outcomes (1)
the efficacy of topical finasteride was determined by comparison of mean hair thickness before and after medication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startFeb 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HirsutismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Firuzgar hospital affiliated to Iran University of Medical Sciences
- Investigators
- iraj heydari, professor assistant, Study director, endocrine and metabolism centre of Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564252
- Sponsor's protocol ID
- 84-5-6886
- Other IDs
- IUMS127
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Finasteride in the Treatment of Idiopathic Hirsutism
- ClinicalTrials.gov ID
- NCT00564252
- Acronym / sponsor ID
- 84-5-6886
- Conditions
- Idiopathic Hirsutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Firuzgar hospital affiliated to Iran University of Medical Sciences
- Study start
- Feb 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Nov 2007 (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 purpose of this study is to evaluate the efficacy of topical Finasteride in the treatment of idiopathic hirsutism
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Idiopathic hirsutism which is defined as normal levels of androgens and normal ovulation
- Normal serum prolactin
Key exclusion criteria (2 listed)
- Pregnancy
- Simultaneous use of other drugs for the treatment of hirsutism
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 |
|---|---|---|
| topical finasteride0.2%topical(cream)finasteride twice a day for six months | Drug | – |
Primary outcome
the efficacy of topical finasteride was determined by comparison of Ferriman-Gallwey score before and after medication
Time frame: 6 months
1 secondary outcome
the efficacy of topical finasteride was determined by comparison of mean hair thickness before and after medication
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
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.
iraj heydari, professor assistant study director
endocrine and metabolism centre of Iran University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing topical finasteride in people with Idiopathic Hirsutism, run by Iran University of Medical Sciences.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 efficacy of topical finasteride was determined by comparison of Ferriman-Gallwey score before and after medication (time frame: 6 months). 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 27 Nov 2007.