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

January 23, 2017 updated by: William Beaumont Hospitals

The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the Global Response Assessment (GRA) for vulvar pain.
Time Frame: After 1 month of intervention
Those "moderately" or "markedly" improved on the GRA are responders
After 1 month of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in vulvar pain levels
Time Frame: After 1 month of intervention
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
After 1 month of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Investigators

  • Principal Investigator: Donna J Carrico, WHNP, MS, William Beaumont Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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