Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|Erectile Dysfunction Benign Prostatic Hyperplasia||Drug: Udenafil Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change from Baseline in Total International Prostate Symptom Score (IPSS) [ Time Frame: Baseline to Week 12 ]The IPSS is an 8 question (7 symptom questions + 1 quality of life question) tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The 7 symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 1 to 5 for a total of maximum 35 points. The 8th question of quality of life is assigned a score of 1 to 6. The total score correlates as follows: 0-7 mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic.
- Change from Baseline in Erectile Function Domain of the International Index of Erectile Function (IIEF) [ Time Frame: Baseline and Week 12 ]The IIEF is a standardised and validated 15-item self-evaluation scale that provides pre-post treatment clinic evaluations of erectile function, orgasmic function, sexual desire, satisfaction in sexual intercourse and general satisfaction. The Erectile Function domain (6-item) provides pre-post treatment evaluations of erectile function.
- Participants with Adverse Events [ Time Frame: 12 weeks ]AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Udenafil 25 mg
Udenafil 25 mg, tablets, orally, once daily for 12 weeks.
Experimental: Udenafil 50 mg
Udenafil 50 mg, tablets, orally, once daily for 12 weeks.
Experimental: Udenafil 75 mg
Udenafil 75 mg, tablets, orally, once daily for 12 weeks.
Placebo Comparator: Placebo
Udenafil placebo-matching tablets, orally, once daily for 12 weeks.
Udenafil placebo-matching tablets
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967251
|Mexico, Distrito Federal, Mexico|
|Mexico, Estado de México, Mexico|
|Guadalajara, Jalisco, Mexico|
|Morelia, Michoacán, Mexico|
|Cuernavaca, Morelos, Mexico|
|Monterrey, Nuevo León, Mexico|
|Cholula, Puebla, Mexico|
|Study Director:||Medical Director||Takeda|