VulvodyniaNCT01295268
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
A study testing Emu Oil and Inert oil in people with Vulvodynia and Vestibulodynia, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia, Vestibulodynia
- What is being tested?
- Emu Oil and Inert oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Beaumont Women's Urology Center
Royal Oak, Michigan, 48073
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvodynia, Vestibulodynia
- Being tested
- Emu Oil, Inert oil
- Keywords
- Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emu OilOther
Subjects will apply a specified amount of emu oil daily to area.
Inert oilOther
A specified amount of inert oil will be applied daily to area.
| Study group | Role | What they receive |
|---|---|---|
| Emu Oil | Active comparator | Not described Receives: Other: Emu Oil |
| inert oil | Placebo comparator | Not described Receives: Other: Inert oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the Global Response Assessment (GRA) for vulvar pain.
Those "moderately" or "markedly" improved on the GRA are responders
Measured: After 1 month of intervention
Secondary outcomes (1)
The change in vulvar pain levels
Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.
Measured: After 1 month of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: enrollment volume due to placebo arm of trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna J Carrico, WHNP, MS, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295268
- Sponsor's protocol ID
- 2011-019
- Status last verified
- May 2012
- First submitted
- 10 Feb 2011
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT01295268
- Acronym / sponsor ID
- 2011-019
- Conditions
- Vulvodynia, Vestibulodynia
- Keywords
- Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment volume due to placebo arm of trial
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emu Oil | Active comparator | Other: Emu Oil |
| inert oil | Placebo comparator | Other: Inert oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emu OilSubjects will apply a specified amount of emu oil daily to area. | Other | Emu Oil |
| Inert oilA specified amount of inert oil will be applied daily to area. | Other | inert oil |
Primary outcome
The change in the Global Response Assessment (GRA) for vulvar pain.
Time frame: After 1 month of intervention
Those "moderately" or "markedly" improved on the GRA are responders
1 secondary outcome
The change in vulvar pain levels
Time frame: After 1 month of intervention
Results and safety
The study was stopped early (reason given: enrollment volume due to placebo arm of trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
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Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna J Carrico, WHNP, MS principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emu Oil and Inert oil in people with Vulvodynia and Vestibulodynia, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment volume due to placebo arm of trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the Global Response Assessment (GRA) for vulvar pain. (time frame: After 1 month of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.