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OpenTrials
Completed

NCT Number: NCT01939184

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Warner Chilcott Investigational Study Site, Homewood, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

WC3055

Drug

12.5, 25, 50 or 75 mg dose

Placebo

Other

Placebo

Primary outcomes

  1. Change from Baseline in Total IPSS (International Prostate Symptom Score)

    Time frame: Final Visit (Week 12 or final visit)

    Sum of Questions 1-7.

Secondary outcomes

  1. Change from Baseline Total IPSS

    Time frame: Week 4

    Sum of Questions 1-7.

  2. Change from Baseline Total IPSS

    Time frame: Week 8

    Sum of Questions 1-7.

  3. Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score

    Time frame: Week 4

    Questions 1, 2, 3, 4, 5, & 15.

  4. Change from Baseline IIEF-EF Domain Score

    Time frame: Week 8

    Questions 1, 2, 3, 4, 5, & 15.

  5. Change from Baseline IIEF-EF Domain Score

    Time frame: Week 12

    Questions 1, 2, 3, 4, 5, & 15.

  6. Change from Baseline IIEF-EF Domain Score

    Time frame: Final Visit (Week 12 or Final Visit)

    Questions 1, 2, 3, 4, 5, & 15.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2013
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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