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

Vulvodynia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01295268
• Other study ID #: 2011-019
• Status: Terminated
• Phase: N/A
• First received: February 10, 2011
• Last updated: January 23, 2017
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Other:
• Emu Oil
Subjects will apply a specified amount of emu oil daily to area.
• Inert oil
A specified amount of inert oil will be applied daily to area.

Locations

Country	Name	City	State
United States	Beaumont Women's Urology Center	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the Global Response Assessment (GRA) for vulvar pain.	Those "moderately" or "markedly" improved on the GRA are responders	After 1 month of intervention
Secondary	The change in vulvar pain levels	Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.	After 1 month of intervention