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

NCT02862483 | Unknown Phase 3

• 1 other identifier: ID-TATA-301
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Prostatic Hyperplasia; Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• The change of total IPSS(International prostate symptom score)

  From baseline at week 12

• The change of IIEF-EF(International Index of Erectile Function sum of questions-Erectile function) domain

  From baseline at week 12

Secondary Outcomes (15)

• The change of total IPSS(International prostate symptom score)

  From baseline at week 4,8

• The change of total IPSS(International prostate symptom score) sub score (storage, voiding)

  From baseline at week 4,8 and 12

• The change of IPSS(International prostate symptom score) QoL(Quality of Life)

  From baseline at week 4,8 and 12

• The change of Qmax(maximum urinary flow rate)

  From baseline at week 4,8 and 12

• The change of PVR(Post Void Residual Volume)

  From baseline at week 4,8 and 12

Study Arms (2)

Experimental

EXPERIMENTAL

Tamsulosin 0.2mg and Tadalafil 5mg

Drug: Tamsulosin 0.2mg; Drug: Tadalafil 5mg

Comparator

ACTIVE COMPARATOR

placebo for Tamsulosin 0.2mg and Tadalafil 5mg

Drug: Tadalafil 5mg; Drug: Placebo for Tamsulosin

Interventions

Tamsulosin 0.2mg DRUG

Experimental

Tadalafil 5mg DRUG

Comparator; Experimental

Placebo for Tamsulosin DRUG

Comparator

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who have hypersensitivity to investigational product or sulfa medications

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Catholic university of korea, Seoul ST. Mary's Hospital.

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Erectile Dysfunction

Interventions

Tamsulosin; Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Ji-yoon Choi

CONTACT

jychoi@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 11, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)