What we are studying
Structure: Multicenter, randomized, double-blind, placebo-controlled study designed to determine the effect of treatment with setipiprant tablets 1000 mg BID on scalp hair growth.
Duration: Approximately 32 weeks (enrollment through exit)
Study Treatment Group: Setipiprant tablets 1000 mg BID
Control: Placebo BID and finasteride 1 mg once daily
Dosage/Dose Regimen: Setipiprant tablets 1000 mg BID, placebo tablets BID, or finasteride 1 mg once daily taken orally for 24 weeks
Enrollment/Stratification: Eligible non-PK subjects will be randomly assigned to 1 of 3 treament groups in a 2:2:1 ratio to receive setipiprant tablets 1000 mg BID, placebo BID, or finasteride 1 mg once daily. PK subjects will be randomly assigned to 1 of 2 treatment groups in a 5:1 ratio, setipiprant tablets 1000 mg BID or placebo BID. Non-PK subjects will be stratified by baseline age, 18 to 34 and 35 to 41 years.
Visit Schedule: Seven scheduled study visits (screening [Days ?28 to ?1], Day 1 [baseline], Weeks 4, 8, 16, 24 [treatment period], and Week 32 or early exit visit [follow-up]).
$50 for Each Completed Visit or a Total of $350