Enoxaparin as Treatment for Vulvodynia

Sponsor

Western Galilee Hospital-Nahariya (Other)

Overall Status

Completed

CT.gov ID

NCT00874484

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2009

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

vestibular pain [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

women with vulvodynia

Exclusion Criteria:

women without vulvodynia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Galilee Hospital- Nahariya	Nahariya		Israel	22100

Sponsors and Collaborators

Western Galilee Hospital-Nahariya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Jacob Bornstein, Chair, Dpt Obstetrics & Gynecology, Western Galilee Hospital-Nahariya

ClinicalTrials.gov Identifier:

NCT00874484

Other Study ID Numbers:

JB 2409

First Posted:

Apr 2, 2009

Last Update Posted:

May 20, 2020

Last Verified:

May 1, 2020

Additional relevant MeSH terms:

Vulvodynia

Enoxaparin

Study Results

No Results Posted as of May 20, 2020