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

• Sponsor: IlDong Pharmaceutical Co Ltd (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02862483
• Collaborator: (none)
• Enrollment: 330
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 27.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia; Erectile Dysfunction	Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg; Drug: Placebo for Tamsulosin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2016
• Anticipated Primary Completion Date: Mar 1, 2017
• Anticipated Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Tamsulosin 0.2mg and Tadalafil 5mg	Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg
Active Comparator: Comparator placebo for Tamsulosin 0.2mg and Tadalafil 5mg	Drug: Tadalafil 5mg; Drug: Placebo for Tamsulosin

Outcome Measures

Primary Outcome Measures

1. The change of total IPSS(International prostate symptom score) [From baseline at week 12]

2. The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain [From baseline at week 12]

Secondary Outcome Measures

1. The change of total IPSS(International prostate symptom score) [From baseline at week 4,8]

2. The change of total IPSS(International prostate symptom score) sub score (storage, voiding) [From baseline at week 4,8 and 12]

3. The change of IPSS(International prostate symptom score) QoL(Quality of Life) [From baseline at week 4,8 and 12]

4. The change of Qmax(maximum urinary flow rate) [From baseline at week 4,8 and 12]

5. The change of PVR(Post Void Residual Volume) [From baseline at week 4,8 and 12]

6. PGIC(Patient Global Impression of change) score [At week 12]

7. CGIC(Clinician Global Impression of change) score [At week 12]

8. The change of IIEF (International Index of Erectile Function sum of questions) total score [From baseline at week 4,8 and 12]

9. The change of IIEF-IS(International Index of Erectile Function sum of questions-Intercourse satisfaction) domain score measured by IIEF question number 6~8 [From baseline at week 4,8 and 12]

10. The change of OS(Overall satisfaction) domain score measured by IIEF question number13 and 14 [From baseline at week 4,8 and 12]

11. The change of OF(Orgasmic function) domain score measured by IIEF question number 9 and 10) [From baseline at week 4,8 and 12]

12. 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 [From baseline at week 4,8]

13. The change of IIEF(International Index of Erectile Function) score about questions number 3 and 4 [From baseline at week 12]

14. The percentage of patients who have more than 4 point about IIEF questions number 3 and 4 [From baseline at week 12]

15. The percentage of patients who have increased score about IIEF questions number 3 and 4(at least 1 point) compared to the baseline [From baseline at week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic university of korea, Seoul ST. Mary's Hospital.	Seoul		Korea, Republic of

Sponsors and Collaborators

• IlDong Pharmaceutical Co Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IlDong Pharmaceutical Co Ltd
• ClinicalTrials.gov Identifier: NCT02862483
• Other Study ID Numbers: ID-TATA-301
• First Posted: Aug 11, 2016
• Last Update Posted: Aug 12, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hyperplasia; Tadalafil; Tamsulosin

Study Results

No Results Posted as of Aug 12, 2016