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NCT00422734 · ClinicalTrials.gov registry record · Phase 3

Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
342
Enrollment target

NCT00422734: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00422734 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 342 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00422734, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
342 participants
Enrollment target

Study Summary

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

Primary Outcome

Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.

Interventions

  • DRUG Placebo
  • DRUG tadalafil

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 2006-11
Est. Completion 2008-01
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00422734 record still lists

NCT00422734 is an interventional study that assigns participants to a tested intervention. The registered 342 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 (56% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00422734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00422734 about?

NCT00422734 is a clinical study titled "Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life". To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

What is the current status of trial NCT00422734?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 342 participants. The study started on 2006-11. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00422734?

The interventions under investigation include: Placebo (DRUG), tadalafil (DRUG).

Who is sponsoring clinical trial NCT00422734?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00422734's enrollment target sits among peer trials

342 1053rd of 2000 higher than 948 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

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Source: ClinicalTrials.gov NCT00422734, the US trial registry maintained by the National Library of Medicine. NCT00422734 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.