NCT01304589

Savella in Treatment for Provoked Vestibulodynia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: Female
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an 18-week, open-label, flexible-dose "proof of concept" trial where women with a diagnosis of vestibulodynia will be evaluated at baseline for eligibility. Eligible patients will be openly treated with 200 mg/d milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involves 4 phases: screening and washout, baseline assessment, dose escalation, and stable-dose phase (Figure 1). After completing a 2-week washout of prohibited medications, patients will enter a 2-week baseline period, where they will be trained in the use of daily diaries and the tampon test, and baseline safety and efficacy data will be recorded. Patients who continue to meet the eligibility criteria at the end of the baseline period will begin a 6-week period of dose escalation. All patients will be scheduled to receive a total of 12 weeks of stable dose treatment after the 6-week dose-escalation period for a total of 18 weeks of drug exposure.

Conditions

• Vestibulodynia
• Vulvodynia

Interventions

Type	Name	Description
DRUG	Milnacipran	6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-02-25
• Last updated: 2018-06-11
• Results posted: 2014-04-02

Locations

1 site across 1 country: United States