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
  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.

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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:
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
Genital Diseases, Female
Vulvar Diseases

ClinicalTrials.gov processed this record on October 22, 2014