Enoxaparin as Treatment for Vulvodynia

This study has been completed.
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
First received: March 31, 2009
Last updated: October 17, 2011
Last verified: October 2011
The investigators hypothesize that injections of Low molecular weight heparin (LMWH) [enoxaparin] will reduce pain in women with vulvodynia.

Condition Intervention Phase
Drug: Clexane (enoxaparin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enoxaparin as Treatment for Vulvar Vestibulitis Syndrome - Vulvodynia

Resource links provided by NLM:

Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • vestibular pain [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Clexane (enoxaparin)
One arm receives enoxoparin, second arm receives saline
Placebo Comparator: 2 Drug: Clexane (enoxaparin)
One arm receives enoxoparin, second arm receives saline


Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women with vulvodynia

Exclusion Criteria:

  • women without vulvodynia
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00874484

Western Galilee Hospital- Nahariya
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Jacob Bornstein, Chair, Dpt Obstetrics & Gynecology, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT00874484     History of Changes
Other Study ID Numbers: JB 2409 
Study First Received: March 31, 2009
Last Updated: October 17, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Genital Diseases, Female
Vulvar Diseases

ClinicalTrials.gov processed this record on May 26, 2016