NCT01967251

Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction

A Randomized, Triple Blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Dose Response of Udenafil for 12 Weeks in Mexican Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, dose-response and safety of udenafil 25 mg, 50 mg and 75 mg every day (q.d.) for 12 weeks in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH and for the treatment of erectile dysfunction (ED).

Detailed description

The drug being tested in this study is called Udenafil. Udenafil is being tested to treat lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and for the treatment of erectile dysfunction (ED). This study will look at the change in lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and in erectile dysfunction (ED) in people who take Udenafil. The study will enroll approximately 950 patients. Participants taking BPH or ED medication will enter a 4-week wash out period. Patients not previously treated and those who accomplished the wash out period will enter a placebo (dummy inactive pill) lead-in period of another 4 weeks. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Udenafil 25 mg * Udenafil 50 mg * Udenafil 75 mg * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take one tablet at the same time each day throughout the study, and will be asked to keep a Sexual Encounter Profile (SEP) diary. This multi-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 20 weeks. Participants will make 6 visits to the clinic.

Conditions

• Erectile Dysfunction
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Udenafil	Udenafil tablets
DRUG	Placebo	Udenafil placebo-matching tablets

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-10-22
• Last updated: 2016-03-04

Locations

8 sites across 1 country: Mexico