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

NCT ID: NCT01295268

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-08-31

Brief Summary

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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

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* 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.

Conditions

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Vulvodynia Vestibulodynia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Emu Oil

Group Type ACTIVE_COMPARATOR

Emu Oil

Intervention Type OTHER

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

inert oil

Group Type PLACEBO_COMPARATOR

Inert oil

Intervention Type OTHER

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

Interventions

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Emu Oil

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

Intervention Type OTHER

Inert oil

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donna J Carrico, WHNP, MS

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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Beaumont Women's Urology Center

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2011-019

Identifier Type: -

Identifier Source: org_study_id

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