Vaginal Odor Clinical Trial
Official title:
"A Comparison Study of the WaterWorks® Douching Device vs. Commercial OTC Douching Device for the Reduction or Abatement of Perceived Vaginal Odor With or Without Complaints of Discharge in Women With no Infectious Causes of Vaginitis"
| Verified date | August 2007 |
| Source | Abbott Research Group |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Enrollment in the study will be open to those subjects who meet the following inclusion criteria: 1. Non-pregnant females, 18 years and older 2. Complaint of abnormal vaginal odor with or without complaints of discharge 3. Subject with perceived, abnormal vaginal odor on the date she is evaluated 4. Odor scale 4 cm or greater (using the subject's perception visual analog rating scale of 10 cm): 0 = no odor 10 = strong offensive odor 5. Subject is not fulfilling Amsel's criteria for BV listed below (only meets 0 or 1 Amsel's criteria) 6. Not treated for Bacterial Vaginosis, VVC, intra-vaginal or oral anti-fungal medications or antibiotics, within the last 14 days of enrollment 7. Willing and able to comply with study requirements 8. Has provided written informed consent Exclusion Criteria: Subjects will be excluded from the enrollment if they have any of the following: 1. Odor scale less than 4 cm (on the Visual Analog rating scale of 10 cm) 2. Subjects with presence of BV 3. Subjects with other lower genital tract infections (e.g., symptomatic VVC, trichomoniasis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus) 4. Subjects with another vaginal or vulvar condition, which would confound the interpretation of clinical response 5. Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days 6. Subjects who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma 7. Positive pregnancy test 8. Any abnormal anatomy or pathology of the subject's vagina 9. Known HIV positive 10. Pap smear >LSIL (untreated or not evaluated) [LSIL = Low-grade squamous intraepithelial lesion] 11. Subject currently having a menstrual period (excluded until completion of period) 12. Subjects with a body mass index (BMI) of 39 or greater 13. Investigator believes that external factor(s) is producing odor |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta Women's Research Institute | Atlanta | Georgia |
| United States | Segal Institute of Clinical Research | Aventura | Florida |
| United States | Wayne State University, Harper Hospital | Detroit | Michigan |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Discovery Research, Inc. | Plantation | Florida |
| United States | University of Oklahoma | Tulsa | Oklahoma |
| United States | Salem Research | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Research Group |
United States,
Infectious Diseases in Obstetrics and Gynecology Volume 2006 (2006), Article ID 95618, 4 pages doi:10.1155/IDOG/2006/95618 /Published results are from ARG sponsored study ARG105.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint of the study is the reduction or abatement of the | |||
| Primary | subject's perceived vaginal odor as determined at Visit 3. | |||
| Primary | This improvement will be measured using a visual analog scale that | |||
| Primary | asks subjects to rate their perception of vaginal odor on a scale that | |||
| Primary | is anchored at two extremes, "no odor", and, "strong offensive odor". | |||
| Secondary | Effects on the vaginal Eco-System will be assessed using the | |||
| Secondary | Lactobacilli score and the Nugent score. The safety profile of the douching | |||
| Secondary | device (Water Works® versus control) will be assessed through the collection | |||
| Secondary | of any reported adverse events. Any adverse event, will be reported in terms | |||
| Secondary | of severity, relationship to treatment, duration, and resolution. |