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Enoxaparin as Treatment for Vulvodynia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00874484
First received: March 31, 2009
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

The investigators hypothesize that injections of Low molecular weight heparin (LMWH) [enoxaparin] will reduce pain in women with vulvodynia.


Condition Intervention Phase
Vulvodynia
 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:

U.S. FDA Resources

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

  Eligibility

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

Inclusion Criteria:

  • women with vulvodynia

Exclusion Criteria:

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

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

No publications provided by Western Galilee Hospital-Nahariya

Additional 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:
Vulvar Vestibulitis
Vulvodynia
Vulvitis
Vulvar Diseases
Genital Diseases, Female
Enoxaparin
Anticoagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013