Savella in Treatment for Provoked Vestibulodynia
|ClinicalTrials.gov Identifier: NCT01304589|
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : April 2, 2014
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vestibulodynia Vulvodynia||Drug: Milnacipran||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Trial of Milnacipran in the Treatment of Women With Provoked Vestibulodynia|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
This was an 18-week, open-label, flexible-dose exploratory trial where eligible patients were treated with 200 mg/day of milnacipran (or the maximum tolerated dose) for a total of 12 weeks. The study design involved 3 phases: screening and baseline assessment, dose escalation and stable-dose phase. All women received 12 weeks of stable dose treatment after a 6-week dose-escalation period for a total of 18 weeks of drug exposure.
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
- Pain Rating Index [ Time Frame: 18 weeks ]The Pain Rating Index is a component of the McGill Pain Questionnaire which measures sensory and affective components of pain. "0" equals no pain to "45" equals severe pain. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
- Tampon Pain [ Time Frame: 18 weeks ]"0" equals no pain with tampon insertion to "10" equals worse pain imaginable with tampon insertion. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
- Coital Pain [ Time Frame: 18 weeks ]"0" equals no pain with intercourse to "10" equals worse imaginable pain with intercourse. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
- 24-hour Vulvar Pain [ Time Frame: 18 weeks ]"0" equals no vulvar pain within the last 24 hours to "10" equals worse imaginable vulvar pain within the last 24 hours. This measure was used to measure mean values at baseline and at 18 weeks post-treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|