Study of Emu Oil vs. Placebo for Vulvar Pain in Women.

This study has been terminated.

(enrollment volume due to placebo arm of trial)

Sponsor:

Information provided by (Responsible Party):

Donna Carrico, William Beaumont Hospitals

ClinicalTrials.gov Identifier:

NCT01295268

First received: February 10, 2011

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Purpose

The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits.

A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.

Condition	Intervention
Vulvodynia Vestibulodynia	Other: Emu Oil Other: Inert oil

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

The change in the Global Response Assessment (GRA) for vulvar pain. [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]
Those "moderately" or "markedly" improved on the GRA are responders

Secondary Outcome Measures:

The change in vulvar pain levels [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.

Enrollment:	1
Study Start Date:	February 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Emu Oil	Other: Emu Oil Subjects will apply a specified amount of emu oil daily to area.
Placebo Comparator: inert oil	Other: Inert oil A specified amount of inert oil will be applied daily to area.

Detailed Description:

Women of all ages with vulvar pain may participate in this trial.
Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study.
At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with vulvar pain upon q-tip exam of > 3/10 at 2 or more sites tested.
Age 18 or older.
Capable of giving informed consent.
Capable and willing to follow all study procedures.

Exclusion Criteria:

Pregnant women or those intending to become pregnant during the study period.
Vaginitis (may be treated, then tested later).
Vulvar disease (other than vulvodynia)—lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation.
The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
Neuropathy.
Currently in pelvic floor physical therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295268

Locations

United States, Michigan
Beaumont Women's Urology Center
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Donna J Carrico, WHNP, MS

William Beaumont Hospitals

More Information

Additional Information:

Beaumont Women's Urology Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Donna Carrico, WHNP, MS/PI, William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT01295268 History of Changes
Other Study ID Numbers:	2011-019
Study First Received:	February 10, 2011
Last Updated:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:

Vulvar pain
Vulvodynia
Vestibulodynia
Vulvar vestibulitis

Additional relevant MeSH terms:

Vulvodynia
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013

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