This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.
This open-label extension study is designed to further assess the long-term safety and efficacy of MCS-2. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-TWN-a will be eligible for another 40 weeks of MCS-2 treatment at the optimal dose selected after the phase 2b part of MCS-2-US-a. Subjects are limited to those who are currently not being treated medically for BPH or LUTS.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a.
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 36 weeks
Changes from baseline in International Prostate Symptom Score (I-PSS)
Time frame: 36 weeks
Changes from baseline in urine flow rate
Time frame: 36 weeks
Changes from baseline in serum lycopene levels
Time frame: 36 weeks
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