NCT01002222

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

3.1 years

First QC Date

October 25, 2009

Last Update Submit

March 1, 2015

Conditions

Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia

Keywords

Benign Prostatic HyperplasiaMCS-2Multi-CarotenoidsLower Urinary Tract SymptomsInternational prostate symptom score

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAE)

    36 weeks

Secondary Outcomes (3)

  • Changes from baseline in International Prostate Symptom Score (I-PSS)

    36 weeks

  • Changes from baseline in urine flow rate

    36 weeks

  • Changes from baseline in serum lycopene levels

    36 weeks

Study Arms (1)

MCS-2

EXPERIMENTAL
Drug: MCS-2

Interventions

MCS-2DRUG

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.

Also known as: MUS
MCS-2

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a.
  • Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study.

You may not qualify if:

  • Subject has severe LUTS at the last visit under the protocol MCS-2-US-a.
  • Subject is considered ineligible for the study by the investigator(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Allan J Pantuck, MD, MS, FACS

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2009

First Posted

October 27, 2009

Study Start

January 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

US(1)