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

Primary Purpose

Vulvodynia, Vestibulodynia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emu Oil
Inert oil
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvodynia focused on measuring Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beaumont Women's Urology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Emu Oil

inert oil

Arm Description

Outcomes

Primary Outcome Measures

The change in the Global Response Assessment (GRA) for vulvar pain.
Those "moderately" or "markedly" improved on the GRA are responders

Secondary Outcome Measures

The change in vulvar pain levels
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.

Full Information

First Posted
February 10, 2011
Last Updated
January 23, 2017
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01295268
Brief Title
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
Official Title
The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
enrollment volume due to placebo arm of trial
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvodynia, Vestibulodynia
Keywords
Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emu Oil
Arm Type
Active Comparator
Arm Title
inert oil
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Emu Oil
Intervention Description
Subjects will apply a specified amount of emu oil daily to area.
Intervention Type
Other
Intervention Name(s)
Inert oil
Intervention Description
A specified amount of inert oil will be applied daily to area.
Primary Outcome Measure Information:
Title
The change in the Global Response Assessment (GRA) for vulvar pain.
Description
Those "moderately" or "markedly" improved on the GRA are responders
Time Frame
After 1 month of intervention
Secondary Outcome Measure Information:
Title
The change in vulvar pain levels
Description
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
Time Frame
After 1 month of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna J Carrico, WHNP, MS
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Women's Urology Center
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.beaumonthospitals.com/womens-urology-center
Description
Beaumont Women's Urology Center

Learn more about this trial

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

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