Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00379756 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 395
- Enrollment target
NCT00379756: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00379756 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 395 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00379756, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 395 participants
- Enrollment target
Study Summary
This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.
Primary Outcome
The IIEF questionnaire is a validated 15-item instrument that assesses the participant's erectile function over the previous 4 weeks. The IIEF includes 5 domains affecting male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Responses to the IIEF were re-coded using a standard coding method, where more positive responses received a higher score. The EF domain score was calculated as the sum of the re-coded scores from ques
Interventions
- DRUG placebo
- DRUG LEVITRA (vardenafil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2006-05-22 |
| Est. Completion | 2007-05-17 |
| Phase | Phase 4 |
What the finished NCT00379756 record still lists
NCT00379756 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00379756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00379756 about?
NCT00379756 is a clinical study titled "A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia". This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects w...
What is the current status of trial NCT00379756?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 395 participants. The study started on 2006-05-22. Estimated completion is 2007-05-17.
What interventions are being tested in trial NCT00379756?
The interventions under investigation include: placebo (DRUG), LEVITRA (vardenafil) (DRUG).
Who is sponsoring clinical trial NCT00379756?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00379756's enrollment target sits among peer trials
395 218th of 2000 higher than 1,783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
- NCT07207369 · 395 participants · Phase 3
A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
- NCT05633615 · 396 participants · Phase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- NCT06227910 · 396 participants · Phase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- NCT06545331 · 396 participants · Phase 1
Study of XB010 in Subjects With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI