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

Not Applicable

Terminated

• Conditions: Vulvodynia; Vestibulodynia
• Interventions: Other: Emu Oil; Other: Inert oil

• Registration Number: NCT01295268
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-14
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-05
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Emu Oil	Emu Oil	-
inert oil	Inert oil	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The change in vulvar pain levels	After 1 month of intervention	Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.

Trial Locations

Locations (1)

Beaumont Women's Urology Center; 🇺🇸 Royal Oak, Michigan, United States