Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00855582 · ClinicalTrials.gov registry record · Phase 3
A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 606
- Enrollment target
NCT00855582: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00855582 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 606 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00855582, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 606 participants
- Enrollment target
Study Summary
Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.
Primary Outcome
The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-reg
Interventions
- DRUG Placebo
- DRUG Tadalafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00855582 record still lists
NCT00855582 is an interventional study that assigns participants to a tested intervention. The registered 606 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00855582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00855582 about?
NCT00855582 is a clinical study titled "A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia". Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.
What is the current status of trial NCT00855582?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2009-03. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00855582?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT00855582?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00855582's enrollment target sits among peer trials
606 606th of 2000 higher than 1,394 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02342444 · 606 participants · Phase 4
Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)
- NCT02064673 · 608 participants · Phase 3
Adjuvant Curcumin to Assess Recurrence Free Survival in Patients Who Have Had a Radical Prostatectomy
- NCT06091202 · 608 participants · Phase 3
Tele-Collaborative Outreach to Rural Patients With Chronic Pain
- NCT06098144 · 608 participants · Phase 4
Smoking Cessation Program in the Construction Sector
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia