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 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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia|
- The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in women with provoked vestibulodynia (PVD) [ Time Frame: Visit 2 (baseline) thru Visit 6 (End of treatment) - 18 weeks of treatment ] [ Designated as safety issue: No ]The primary outcome measure will be pain ratings on the Pain Rating Index (PRI) of the short-form McGill Pain Questionnaire (SF-MPQ), which consists of 15 representative words from the sensory (n = 11) and affective (N = 4) categories of the standard, long-form (LF-MPQ). On the PRI, each descriptor is ranked by the patient on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe.
- diary-rated coital pain and tampon insertion test pain [ Time Frame: Visit 1 (screening) thru Visit 6 (End of Treatment) - 20 weeks ] [ Designated as safety issue: No ]Secondary outcome measures will include other measures of pain intensity (diary-rated coital and tampon insertion pain), physical functioning, emotional and sexual functioning, global rating of improvement, and quality of life.
|Study Start Date:||October 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 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
Other Name: Savella
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.
|United States, Tennessee|
|Women's Health Specialists, PLLC|
|Germantown, Tennessee, United States, 38138|
|Principal Investigator:||Candace S Brown, PharmD||University of Tennessee Health Science Center|