Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Status:
Not yet recruiting
Trial end date:
2024-11-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of
women with androgenetic alopecia, a type of hormone-imbalanced hair loss.
The main questions to answer are to know about that minoxidil 1mg is as effective as
minoxidil 2% topical solution (comparator product) and is more effective than placebo; and to
ensure treatment with oral minoxidil is safe.
Participants will be assigned randomly to receive one of the following treatment
combinations:
- the test product (oral minoxidil 1 mg, once/day) and the vehicle solution (vehicle means
it looks like the comparator product, but it does not contain an active ingredient, 2
times/day), or
- the placebo tablet (placebo means it looks like the test product, but it does not
contain an active ingredient, once/day) and the comparator product (2% minoxidil
solution, 2 times/day), or
- the placebo tablet (once/day) and the vehicle solution (2 times/day).
The clinical trial will take up to 36 weeks. During this time, patients will come to the
clinical trial centre for 5 times for examinations and will be called by phone twice. At the
visits, the following examinations will be performed: photos of the hair will be taken to
determine hair density, assessment of changes in scalp hair growth, measurement of blood
pressure, pulse, and body temperature, a physical examination, blood withdrawal to determine
any abnormalities in the blood, urine sampling and analysis, performance of ECG, and
evaluation of hypertrichosis (i.e., excessive hair growth over the body). Furthermore,
patients will be asked daily whether they had experienced any side effects or took any new
medications (or changed the dose of a known medication) or underwent any medical procedure.
Also, women of childbearing potential must undergo pregnancy tests in blood and urine.