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

William Beaumont Hospitals logo

William Beaumont Hospitals

Status

Terminated

Conditions

Vestibulodynia
Vulvodynia

Treatments

Other: Emu Oil
Other: Inert oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01295268
2011-019

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

1 participants in 2 patient groups, including a placebo group

Emu Oil
Active Comparator group
Treatment:
Other: Emu Oil
inert oil
Placebo Comparator group
Treatment:
Other: Inert oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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