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enrollment volume due to placebo arm of trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emu Oil | Active Comparator |
| |
| inert oil | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emu Oil | Other | Subjects will apply a specified amount of emu oil daily to area. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the Global Response Assessment (GRA) for vulvar pain. | Those "moderately" or "markedly" improved on the GRA are responders | After 1 month of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The change in vulvar pain levels | Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations. | After 1 month of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna J Carrico, WHNP, MS | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Women's Urology Center | Royal Oak | Michigan | 48073 | United States |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D054515 | Vulvar Vestibulitis |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C575034 | emu Oil |
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| Inert oil |
| Other |
A specified amount of inert oil will be applied daily to area. |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014847 | Vulvitis |