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Enoxaparin as Treatment for Vulvodynia

Primary Purpose

Vulvodynia

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Clexane (enoxaparin)
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
March 31, 2009
Last Updated
May 19, 2020
Sponsor
Western Galilee Hospital-Nahariya
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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

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