Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
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ClinicalTrials.gov Identifier: NCT01325337 |
Recruitment Status
:
Completed
First Posted
: March 29, 2011
Results First Posted
: April 10, 2014
Last Update Posted
: April 10, 2014
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Tracking Information | ||||
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First Submitted Date ICMJE | March 28, 2011 | |||
First Posted Date ICMJE | March 29, 2011 | |||
Results First Submitted Date | March 3, 2014 | |||
Results First Posted Date | April 10, 2014 | |||
Last Update Posted Date | April 10, 2014 | |||
Study Start Date ICMJE | June 2011 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01325337 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
307 | |||
Original Estimated Enrollment ICMJE |
300 | |||
Actual Study Completion Date | September 2012 | |||
Actual Primary Completion Date | August 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 49 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01325337 | |||
Other Study ID Numbers ICMJE | 192024-057 2011-000379-15 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Allergan | |||
Study Sponsor ICMJE | Allergan | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Allergan | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |