Enoxaparin as Treatment for Vulvodynia
Primary Purpose
Vulvodynia
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Clexane (enoxaparin)
Sponsored by
About this trial
This is an interventional treatment trial for Vulvodynia
Eligibility Criteria
Inclusion Criteria:
- women with vulvodynia
Exclusion Criteria:
- women without vulvodynia
Sites / Locations
- Western Galilee Hospital- Nahariya
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
vestibular pain
Secondary Outcome Measures
Full Information
NCT ID
NCT00874484
First Posted
March 31, 2009
Last Updated
May 19, 2020
Sponsor
Western Galilee Hospital-Nahariya
1. Study Identification
Unique Protocol Identification Number
NCT00874484
Brief Title
Enoxaparin as Treatment for Vulvodynia
Official Title
Enoxaparin as Treatment for Vulvar Vestibulitis Syndrome - Vulvodynia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Galilee Hospital-Nahariya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesize that injections of Low molecular weight heparin (LMWH) [enoxaparin] will reduce pain in women with vulvodynia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clexane (enoxaparin)
Intervention Description
One arm receives enoxoparin, second arm receives saline
Primary Outcome Measure Information:
Title
vestibular pain
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with vulvodynia
Exclusion Criteria:
women without vulvodynia
Facility Information:
Facility Name
Western Galilee Hospital- Nahariya
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
22914465
Citation
Farajun Y, Zarfati D, Abramov L, Livoff A, Bornstein J. Enoxaparin treatment for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2012 Sep;120(3):565-72. doi: 10.1097/AOG.0b013e3182657de6.
Results Reference
derived
Learn more about this trial
Enoxaparin as Treatment for Vulvodynia
We'll reach out to this number within 24 hrs