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NCT00450242 · ClinicalTrials.gov registry record · Phase 2
5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00450242: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT00450242 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450242, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
* Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo. * This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis. It compares use of nightly 5% topical lidocaine ointment to placebo ointment. The duration of the study is 8 weeks. 28 women will be in each arm for a total of 56 women in the study.
Primary Outcome
Participants' response upon inquiry.
Interventions
- DRUG Placebo cream
- DRUG 5% topical lidocaine ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
Why NCT00450242 stopped before completion
NCT00450242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo cream is the first listed.
NCT00450242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00450242 about?
NCT00450242 is a clinical study titled "5% Lidocaine Ointment in the Treatment of Vulvar Vestibulitis". * Study Hypothesis: Use of 5% topical lidocaine ointment will result in improved ability to have sexual intercourse and decreased pain scores in women with vestibulitis when compared to placebo. * This is a study to assess if topical lidocaine will improve symptoms in women with vulvar vestibulitis....
What is the current status of trial NCT00450242?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2006-12. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00450242?
The interventions under investigation include: Placebo cream (DRUG), 5% topical lidocaine ointment (DRUG).
Who is sponsoring clinical trial NCT00450242?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00450242's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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