FindTrial
Sign In

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-day Dosing for 12 weeks in Asian Men with Signs and Symptoms of Benign Prostatic Hyperplasia

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Evaluate the Efficacy and Safety of Tadalafil Once-a-day Dosing for 12 weeks in Asian Men with Signs and Symptoms of Benign Prostatic Hyperplasia

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221678
Enrollment
Unknown
Registered
2011-12-21
Start date
2011-12-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms of Benign Prostatic Hyperplasia

Interventions

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 In

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026