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

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Terminated

CT.gov ID

NCT01295268

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.