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NCT01065012 · ClinicalTrials.gov registry record · Phase 3

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

A Phase 3 study, sponsored by Warner Chilcott.

Completed
Registry status
Phase 3
Development phase
1,027
Enrollment target

NCT01065012: Completed Phase 3 study, sponsored by Warner Chilcott.

NCT01065012 is a Phase 3 study that has completed, run by Warner Chilcott. The registered enrollment target is 1,027 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01065012, a Phase 3 study, has completed, sponsored by Warner Chilcott.

COMPLETED
Registry status
Phase 3
Development phase
1,027 participants
Enrollment target

Study Summary

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Interventions

  • DRUG Udenafil 50 mg
  • DRUG Udenafil 100 mg
  • DRUG Udenafil 150 mg
  • DRUG Placebo Matching 50 mg Udenafil
  • DRUG Placebo Matching 100 mg Udenafil

Trial Details

FieldValue
Enrollment Target 1,027 participants
Start Date 2010-01
Est. Completion 2011-02
Phase Phase 3
Warner Chilcott

53 total trials

What the finished NCT01065012 record still lists

NCT01065012 is an interventional study that assigns participants to a tested intervention. Its 1,027 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher).

The record links to 0 conditions, and to 5 interventions - of which Udenafil 50 mg is the first listed.

NCT01065012 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01065012 about?

NCT01065012 is a clinical study titled "Treatment of Erectile Dysfunction - Long Term Safety and Efficacy". Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

What is the current status of trial NCT01065012?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,027 participants. The study started on 2010-01. Estimated completion is 2011-02.

What interventions are being tested in trial NCT01065012?

The interventions under investigation include: Udenafil 50 mg (DRUG), Udenafil 100 mg (DRUG), Udenafil 150 mg (DRUG), Placebo Matching 50 mg Udenafil (DRUG), Placebo Matching 100 mg Udenafil (DRUG).

Who is sponsoring clinical trial NCT01065012?

This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01065012's enrollment target sits among peer trials

1,027 288th of 2000 higher than 1,713 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 NCT01065012, the US trial registry maintained by the National Library of Medicine. NCT01065012 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.