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NCT00734604 · ClinicalTrials.gov registry record · Phase 3

A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

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

Completed
Registry status
Phase 3
Development phase
378
Enrollment target

NCT00734604: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00734604 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 378 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00734604, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
378 participants
Enrollment target

Study Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Primary Outcome

The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.

Interventions

  • DRUG tadalafil once a day [T(OaD)]
  • DRUG sildenafil citrate as needed [S(PRN)]
  • DRUG tadalafil as needed [T(PRN)]

Trial Details

FieldValue
Enrollment Target 378 participants
Start Date 2008-08
Est. Completion 2009-09
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00734604 record still lists

NCT00734604 is an interventional study that assigns participants to a tested intervention. The registered 378 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 (51% lower).

The record links to 0 conditions, and to 3 interventions - of which tadalafil once a day [T(OaD)] is the first listed.

NCT00734604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00734604 about?

NCT00734604 is a clinical study titled "A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.". The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

What is the current status of trial NCT00734604?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 378 participants. The study started on 2008-08. Estimated completion is 2009-09.

What interventions are being tested in trial NCT00734604?

The interventions under investigation include: tadalafil once a day [T(OaD)] (DRUG), sildenafil citrate as needed [S(PRN)] (DRUG), tadalafil as needed [T(PRN)] (DRUG).

Who is sponsoring clinical trial NCT00734604?

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 NCT00734604's enrollment target sits among peer trials

378 988th of 2000 higher than 1,013 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 NCT00734604, the US trial registry maintained by the National Library of Medicine. NCT00734604 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.