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NCT00590590 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
A Phase 2 study, sponsored by Lumara Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT00590590: Completed Phase 2 study, sponsored by Lumara Health.
NCT00590590 is a Phase 2 study that has completed, run by Lumara Health. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00590590, a Phase 2 study, has completed, sponsored by Lumara Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
Primary Outcome
The MDSS consists of a participant rating of their dyspareunia (painful sexual intercourse) on a 0- to 3-point scale. Each numerical value on the scale coincides with a level of pain experienced during sexual intercourse; 0 = no dyspareunia (no pain with intercourse) and 3 = completely prevents intercourse
Interventions
- DRUG placebo
- DRUG lidocaine
- DRUG Lidocaine/Diphenhydramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00590590 record still lists
NCT00590590 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00590590 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00590590 about?
NCT00590590 is a clinical study titled "Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort". This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.
What is the current status of trial NCT00590590?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2007-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00590590?
The interventions under investigation include: placebo (DRUG), lidocaine (DRUG), Lidocaine/Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT00590590?
This trial is sponsored by Lumara Health, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590590's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 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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