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Trial record 10 of 41 for:    "Vulvar Vestibulitis Syndrome"

Savella in Treatment for Provoked Vestibulodynia

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ClinicalTrials.gov Identifier: NCT01304589
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : April 2, 2014
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Candace Brown, MSN, Pharm.D., University of Tennessee

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Vestibulodynia
Vulvodynia
Intervention Drug: Milnacipran
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Milnacipran
Hide Arm/Group Description Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Period Title: Overall Study
Started 31
Completed 18
Not Completed 13
Arm/Group Title Milnacipram
Hide Arm/Group Description Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
Pain Rating Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants
20.0  (8.9)
[1]
Measure Description: 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.
Tampon test   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants
5.14  (3.01)
[1]
Measure Description: "0" equals no pain with tampon insertion to "10" equals worse pain imaginable with tampon insertion.
coital pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants
6.94  (2.51)
[1]
Measure Description: "0" equals no pain with intercourse to "10" equals worse imaginable pain with intercourse.
24-hour vulvar pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 31 participants
2.09  (2.03)
[1]
Measure Description: "0" equals no vulvar pain within the last 24 hours to "10" equals worse imaginable vulvar pain within the last 24 hours.
1.Primary Outcome
Title Pain Rating Index
Hide Description 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.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
22 subjects were eligible and received study medication. Analysis population included all 22 eligible subjects.
Arm/Group Title Milnacipram
Hide Arm/Group Description:
Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.3  (13.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Milnacipram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Tampon Pain
Hide Description "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.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
22 subjects were eligible and received study medication. Analysis population includes all 22 eligible subjects.
Arm/Group Title Milnacipran
Hide Arm/Group Description:
Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.45  (2.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Milnacipran
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.
Method paired T-test
Comments Subjects completed a "tampon insertion pain" test once a week. The values were averaged and compared pre-treatment versus post-treatment.
3.Secondary Outcome
Title Coital Pain
Hide Description "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.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
22 subjects were assigned to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes the 18 eligible subjects who completed all of the study visits.
Arm/Group Title Milnacipram
Hide Arm/Group Description:
Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.43  (2.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Milnacipram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title 24-hour Vulvar Pain
Hide Description "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.
Time Frame 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
22 subjects were randomized to study medication with 18 of the 22 subjects completing all of the study visits. Analysis population includes all 18 eligible subjects who completed all of the study visits.
Arm/Group Title Milnacipram
Hide Arm/Group Description:
Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.73  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Milnacipram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Milnacipram
Hide Arm/Group Description Crossover study
All-Cause Mortality
Milnacipram
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Milnacipram
Affected / at Risk (%) # Events
Total   0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Milnacipram
Affected / at Risk (%) # Events
Total   15/31 (48.39%)    
Gastrointestinal disorders   
nausea   15/31 (48.39%)  20
General disorders   
hot flashes   7/31 (22.58%)  9
Nervous system disorders   
headache   13/31 (41.94%)  15
dizziness   6/31 (19.35%)  10
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Candace Brown
Organization: University of Tennessee Health Science Center
Phone: 901-412-4341
Responsible Party: Candace Brown, MSN, Pharm.D., University of Tennessee
ClinicalTrials.gov Identifier: NCT01304589     History of Changes
Other Study ID Numbers: CSBrown SAV-MD-18
First Submitted: February 24, 2011
First Posted: February 25, 2011
Results First Submitted: December 29, 2013
Results First Posted: April 2, 2014
Last Update Posted: June 11, 2018