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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Savella in Treatment for Provoked Vestibulodynia

ClinicalTrials.gov ID: NCT01304589

Public ClinicalTrials.gov record NCT01304589. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 12:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01304589
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
University of Tennessee
Other
Enrollment
31 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 54 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2010
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012
Last update posted
Jun 10, 2018

2010 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Women's Health Specialists, PLLC Germantown Tennessee 38138

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01304589, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 10, 2018 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01304589 live on ClinicalTrials.gov.

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