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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01295268

Enrollment

Registered

2011-02-14

Start date

2011-02-28

Completion date

2011-08-31

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibulodynia, Vulvodynia

Keywords

Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis

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.

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.

Interventions

OTHEREmu Oil

Subjects will apply a specified amount of emu oil daily to area.

OTHERInert oil

A specified amount of inert oil will be applied daily to area.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026