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Enoxaparin as Treatment for Vulvodynia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874484
First Posted: April 2, 2009
Last Update Posted: October 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya
  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
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

Resource links provided by NLM:


Further study details as provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:

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

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

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
  Contacts and Locations
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
  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
First Submitted: March 31, 2009
First Posted: April 2, 2009
Last Update Posted: October 18, 2011
Last Verified: October 2011

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