Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-27 @ 2:37 PM
Study NCT ID:
NCT01295268
Status:
TERMINATED
Last Update Posted:
2017-01-25
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
Sponsor:
Corewell Health East
Organization:
Study Overview
Official Title:
The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrollment volume due to placebo arm of trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: