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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Milnacipran Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.

Participant Flow:   Overall Study
    Milnacipran
STARTED   31 
COMPLETED   18 
NOT COMPLETED   13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Milnacipram Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.

Baseline Measures
   Milnacipram 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      31 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      31 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   31 
Pain Rating Index [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 20.0  (8.9) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.14  (3.01) 
[1] "0" equals no pain with tampon insertion to "10" equals worse pain imaginable with tampon insertion.
coital pain [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.94  (2.51) 
[1] "0" equals no pain with intercourse to "10" equals worse imaginable pain with intercourse.
24-hour vulvar pain [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.09  (2.03) 
[1] "0" equals no vulvar pain within the last 24 hours to "10" equals worse imaginable vulvar pain within the last 24 hours.


  Outcome Measures

1.  Primary:   Pain Rating Index   [ Time Frame: 18 weeks ]

2.  Secondary:   Tampon Pain   [ Time Frame: 18 weeks ]

3.  Secondary:   Coital Pain   [ Time Frame: 18 weeks ]

4.  Secondary:   24-hour Vulvar Pain   [ Time Frame: 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: csbrown@uthsc.edu



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