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

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. Identifier: NCT01295268
Recruitment Status : Terminated (enrollment volume due to placebo arm of trial)
First Posted : February 14, 2011
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Vestibulodynia Other: Emu Oil Other: Inert oil Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : February 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01295268

United States, Michigan
Beaumont Women's Urology Center
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Donna J Carrico, WHNP, MS William Beaumont Hospitals

Responsible Party: William Beaumont Hospitals Identifier: NCT01295268     History of Changes
Other Study ID Numbers: 2011-019
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: May 2012

Keywords provided by William Beaumont Hospitals:
Vulvar pain
Vulvar vestibulitis

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