Study Stopped
enrollment volume due to placebo arm of trial
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJanuary 25, 2017
May 1, 2012
6 months
February 10, 2011
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The change in vulvar pain levels
After 1 month of intervention
Study Arms (2)
Emu Oil
ACTIVE COMPARATORinert oil
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beaumont Women's Urology Center
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donna J Carrico, WHNP, MS
Corewell Health East
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 14, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 25, 2017
Record last verified: 2012-05