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

This study has been terminated.
(enrollment volume due to placebo arm of trial)
Sponsor:
Information provided by (Responsible Party):
Donna Carrico, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01295268
First received: February 10, 2011
Last updated: May 7, 2012
Last verified: May 2012

February 10, 2011
May 7, 2012
February 2011
August 2011   (final data collection date for primary outcome measure)
The change in the Global Response Assessment (GRA) for vulvar pain. [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]
Those "moderately" or "markedly" improved on the GRA are responders
Same as current
Complete list of historical versions of study NCT01295268 on ClinicalTrials.gov Archive Site
The change in vulvar pain levels [ Time Frame: After 1 month of intervention ] [ Designated as safety issue: No ]
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
Same as current
Not Provided
Not Provided
 
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.

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.

  • 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vulvodynia
  • Vestibulodynia
  • Other: Emu Oil
    Subjects will apply a specified amount of emu oil daily to area.
  • Other: Inert oil
    A specified amount of inert oil will be applied daily to area.
  • Active Comparator: Emu Oil
    Intervention: Other: Emu Oil
  • Placebo Comparator: inert oil
    Intervention: Other: Inert oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01295268
2011-019
No
Donna Carrico, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: Donna J Carrico, WHNP, MS William Beaumont Hospitals
William Beaumont Hospitals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP