JRCT ID: jRCT2080221678
Registered date:21/12/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Signs and Symptoms of Benign Prostatic Hyperplasia |
Date of first enrollment | 21/12/2011 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Tadalafil INN of investigational material : Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosage and Administration for Investigational material : Tadalafil 5mg or Placebo taken orally once-a-day |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 45age old |
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Age maximum | Not applicable |
Gender | Male |
Include criteria | The study population consists of men >_45 years of age who have BPH-LUTS for >6 months at Visit 1. Subjects are not to have taken finasteride for at least 3 months, dutasteride for at least 6 months, or any BPH, OAB, or ED therapy for at least 4 weeks prior to Visit 2. Subjects need to have a total IPSS of>_13. |
Exclude criteria |
Related Information
Primary Sponsor | Eli Lilly Japan K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-111720 |
Contact
Public contact | |
Name | |
Address | 0120-360-605 |
Telephone | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |