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|
- Pain Rating Index [ Time Frame: 18 weeks ] [ 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. Total score - "0" equals no pain to "45" equals severe pain. The paired t-test was used to compare the PRI score at baseline and at 18 weeks or to further clarify, pre-treatment versus post-treatment comparison.
- Tampon Pain [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Subjects completed a "tampon insertion pain" test once a week in their daily diary. The values were averaged and compared pre-treatment versus post-treatment.
- Coital Pain [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Intercourse pain is measured by completing a daily diary
- 24-hour Vulvar Pain [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Measures average vulvar pain over 24-hours on daily diary
|Study Start Date:||October 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304589
|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|