Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01939184

Enrollment

796

Registered

2013-09-11

Start date

2013-08-31

Completion date

2014-04-30

Last updated

2015-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Brief summary

The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.

Interventions

DRUGWC3055

12.5, 25, 50 or 75 mg dose

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* History of LUTS for ≥6 months secondary to BPH * Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Total IPSS (International Prostate Symptom Score)	Final Visit (Week 12 or final visit)	Sum of Questions 1-7.

Secondary

Measure	Time frame	Description
Change from Baseline Total IPSS	Week 4	Sum of Questions 1-7.
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score	Week 4	Questions 1, 2, 3, 4, 5, & 15.
Change from Baseline IIEF-EF Domain Score	Week 8	Questions 1, 2, 3, 4, 5, & 15.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026