CLINICAL TRIALS PROFILE FOR MINOXIDIL (FOR MEN)

505(b)(2) Clinical Trials for MINOXIDIL (FOR MEN)

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01325337 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia	Completed	Allergan	Phase 2	2011-06-01	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.
OTC	NCT01325350 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

All Clinical Trials for MINOXIDIL (FOR MEN)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00151515 ↗	A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	2003-10-01	The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.
NCT00175617 ↗	Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss	Completed	University of British Columbia	Phase 2	2005-09-01	This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
NCT00418730 ↗	Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss	Completed	Neosil, Inc.	Phase 2	2007-01-01	The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.

Clinical Trial Conditions for MINOXIDIL (FOR MEN)

Condition Name

Condition Name for MINOXIDIL (FOR MEN)
Intervention	Trials
Androgenetic Alopecia	21
Alopecia Areata	8
Alopecia	7
Female Pattern Hair Loss	6

Condition MeSH

Condition MeSH for MINOXIDIL (FOR MEN)
Intervention	Trials
Alopecia	49
Alopecia Areata	48
Hypotrichosis	2
Hypertension	2

Clinical Trial Locations for MINOXIDIL (FOR MEN)

Trials by Country

Trials by Country for MINOXIDIL (FOR MEN)
Location	Trials
United States	58
Egypt	9
Thailand	7
Germany	7
France	5

Trials by US State

Trials by US State for MINOXIDIL (FOR MEN)
Location	Trials
Texas	6
Minnesota	5
Ohio	5
Oregon	4
Florida	4

Clinical Trial Progress for MINOXIDIL (FOR MEN)

Clinical Trial Phase

Clinical Trial Phase for MINOXIDIL (FOR MEN)
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MINOXIDIL (FOR MEN)
Clinical Trial Phase	Trials
Completed	33
Recruiting	10
Not yet recruiting	8

Clinical Trial Sponsors for MINOXIDIL (FOR MEN)

Sponsor Name

Sponsor Name for MINOXIDIL (FOR MEN)
Sponsor	Trials
Mae Fah Luang University Hospital	5
Assiut University	4
Cairo University	2

Sponsor Type

Sponsor Type for MINOXIDIL (FOR MEN)
Sponsor	Trials
Other	57
Industry	23
U.S. Fed	2