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NCT01304589 · ClinicalTrials.gov registry record · Phase 3
Savella in Treatment for Provoked Vestibulodynia
A Phase 3 study, sponsored by University of Tennessee.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT01304589: Completed Phase 3 study, sponsored by University of Tennessee.
NCT01304589 is a Phase 3 study that has completed, run by University of Tennessee. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01304589, a Phase 3 study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determine whether associated symptoms in PVD, including psychological distress, impairment of sexual function, physical function, and quality of life, are correlated with a reduction in vulvar pain.
Primary Outcome
The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Interventions
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01304589 record still lists
NCT01304589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Milnacipran is the first listed.
NCT01304589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01304589 about?
NCT01304589 is a clinical study titled "Savella in Treatment for Provoked Vestibulodynia". The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The investigators will also determ...
What is the current status of trial NCT01304589?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2010-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01304589?
The interventions under investigation include: Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01304589?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01304589's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 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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