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NCT00512707 · ClinicalTrials.gov registry record · Phase 4
Effect of Testosterone in Men With Erectile Dysfunction
A Phase 4 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
NCT00512707: Completed Phase 4 study, sponsored by Boston University.
NCT00512707 is a Phase 4 study that has completed, run by Boston University. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00512707, a Phase 4 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this placebo-controlled study is to determine if testosterone replacement therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R) treatment in men who have erectile dysfunction (ED) and low testosterone levels.
Primary Outcome
IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with Erectile Function domain range of 1 to 30 with higher scores representing better function.
Interventions
- DRUG Testosterone gel
- DRUG Sildenafil citrate (open label)
- OTHER Placebo gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2006-11 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
What the finished NCT00512707 record still lists
NCT00512707 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Testosterone gel is the first listed.
NCT00512707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00512707 about?
NCT00512707 is a clinical study titled "Effect of Testosterone in Men With Erectile Dysfunction". The purpose of this placebo-controlled study is to determine if testosterone replacement therapy, administered by transdermal gel, can improve the response to sildenafil (Viagra R) treatment in men who have erectile dysfunction (ED) and low testosterone levels.
What is the current status of trial NCT00512707?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2006-11. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00512707?
The interventions under investigation include: Testosterone gel (DRUG), Sildenafil citrate (open label) (DRUG), Placebo gel (OTHER).
Who is sponsoring clinical trial NCT00512707?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00512707's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 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
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