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Enoxaparin as Treatment for Vulvodynia

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ClinicalTrials.gov Identifier: NCT00874484
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya

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

Condition or disease Intervention/treatment Phase
Vulvodynia Drug: Clexane (enoxaparin) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enoxaparin as Treatment for Vulvar Vestibulitis Syndrome - Vulvodynia
Study Start Date : March 2009
Primary Completion Date : April 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. vestibular pain [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with vulvodynia

Exclusion Criteria:

  • women without vulvodynia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874484


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

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
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Vulvodynia
Vulvar Diseases
Genital Diseases, Female