Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
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 another 24 weeks of MCS-2 treatment. Optimal dosage of MCS-2 as the active treatment given under the protocol MCS-2-US-a phase 3 part will be given daily in the extension period. No placebo arm is planned in the study.
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Six-Month Extension of Protocol MCS-2-TWN-a to Further Evaluate the Efficacy and Safety of MCS-2 for the Treatment of Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects|
- Incidence of treatment-emergent adverse events (TEAE) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
- Changes from baseline in International Prostate Symptom Score (I-PSS) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in urine flow rate [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Changes from baseline in serum lycopene levels [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
Other Name: MUS
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 24 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. Subjects will return for visits every 8 weeks for evaluation. Subjects can take lycopene-containing vegetables and fruits during this open-label extension study, but they are advised to refrain from extra source of lycopene supplementation, such as lycopene extracts made into a capsule, soft gel, or crude granule extracts.
|Contact: Fu-Feng Kuoemail@example.com|
|United States, California|
|David Geffen School of Medicine at UCLA||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Allan J Pantuck, MD, MS, FACS Apantuck@mednet.ucla.edu|
|Principal Investigator:||Allan J Pantuck, MD, MS, FACS||University of California, Los Angeles|