Clinical trial NCT02862483: The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Erectile Dysfunction
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 330
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of the combination of tamsulosin and tadalafil in men with lower urinary tract symptoms due to benign prostatic hyperplasia and Erectile Dysfunction: a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial


Eligibility criteria: Inclusion Criteria:

Visit1

* Male aged 45 years old or older
* Subjects who have PSA ≤ 4.0 ng/mL Visit2
* Subjects who have Total IPSS score ≥ 13
* Subjects who have IIEF-EF domain ≤ 24 and each point below 3 in question 3 and 4

Exclusion Criteria:

* Subjects who have hypersensitivity to investigational product or sulfa medications

Primary outcomes:
measure: The change of total IPSS(International prostate symptom score)
timeFrame: From baseline at week 12
measure: The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain
timeFrame: From baseline at week 12
Secondary outcomes:
measure: The change of total IPSS(International prostate symptom score)
timeFrame: From baseline at week 4,8
measure: The change of total IPSS(International prostate symptom score) sub score (storage, voiding)
timeFrame: From baseline at week 4,8 and 12
measure: The change of IPSS(International prostate symptom score) QoL(Quality of Life)
timeFrame: From baseline at week 4,8 and 12
measure: The change of Qmax(maximum urinary flow rate)
timeFrame: From baseline at week 4,8 and 12
measure: The change of PVR(Post Void Residual Volume)
timeFrame: From baseline at week 4,8 and 12
measure: PGIC(Patient Global Impression of change) score
timeFrame: At week 12
measure: CGIC(Clinician Global Impression of change) score
timeFrame: At week 12
measure: The change of IIEF (International Index of Erectile Function sum of questions) total score
timeFrame: From baseline at week 4,8 and 12
measure: The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8
timeFrame: From baseline at week 4,8 and 12
measure: The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14
timeFrame: From baseline at week 4,8 and 12
measure: The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10)
timeFrame: From baseline at week 4,8 and 12
measure: The change of IIEF-EF domain(International Index of Erectile Function sum of questions-Erectile function) score measured by IIEF question number 1~5 and 15
timeFrame: From baseline at week 4,8
measure: The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4
timeFrame: From baseline at week 12
measure: The percentage of patients who have more than 4 point about IIEF questions number 3 and 4
timeFrame: From baseline at week 12
measure: The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline
timeFrame: From baseline at week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic university of korea, Seoul ST. Mary's Hospital.
Study officials:
References: