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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 is a Phase 3 study that has completed, run by University of Tennessee. The registered enrollment target is 31 participants.
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.
Interventions
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01304589
The ClinicalTrials.gov registry entry for NCT01304589 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Milnacipran is the first listed.
NCT01304589 reports 0 study locations.
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.
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