Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
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|ClinicalTrials.gov Identifier: NCT01295268|
Recruitment Status : Terminated (enrollment volume due to placebo arm of trial)
First Posted : February 14, 2011
Last Update Posted : January 25, 2017
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|
- 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|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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.
- 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
- The change in vulvar pain levels [ Time Frame: After 1 month of intervention ]Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
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 ClinicalTrials.gov identifier (NCT number): NCT01295268
|United States, Michigan|
|Beaumont Women's Urology Center|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Donna J Carrico, WHNP, MS||William Beaumont Hospitals|