Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
Status unconfirmed · Not applicable
Conditions studied: Vaginal Odor
In brief
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
Key facts
- Study ID
- NCT00417365
- Run by
- Abbott Research Group
- People needed
- 100
- Starts
- 2006-08-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2007-08-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Enrollment in the study will be open to those subjects who meet the following inclusion criteria:
- Non-pregnant females, 18 years and older
- Complaint of abnormal vaginal odor with or without complaints of discharge
- Subject with perceived, abnormal vaginal odor on the date she is evaluated
- 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
- Subject is not fulfilling Amsel's criteria for BV listed below (only meets 0 or 1 Amsel's criteria)
- Not treated for Bacterial Vaginosis, VVC, intra-vaginal or oral anti-fungal medications or antibiotics, within the last 14 days of enrollment
- Willing and able to comply with study requirements
- Has provided written informed consent
You may not qualify if…
- Subjects will be excluded from the enrollment if they have any of the following:
- Odor scale less than 4 cm (on the Visual Analog rating scale of 10 cm)
- Subjects with presence of BV
- Subjects with other lower genital tract infections (e.g., symptomatic VVC, trichomoniasis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus)
- Subjects with another vaginal or vulvar condition, which would confound the interpretation of clinical response
- Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days
- Subjects who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma
- Positive pregnancy test
- Any abnormal anatomy or pathology of the subject's vagina
- Known HIV positive
- Pap smear >LSIL (untreated or not evaluated) [LSIL = Low-grade squamous intraepithelial lesion]
- Subject currently having a menstrual period (excluded until completion of period)
- Subjects with a body mass index (BMI) of 39 or greater
- Investigator believes that external factor(s) is producing odor
Where it is running
- Wayne State University, Harper Hospital — Detroit, Michigan, United States (enrolling)
- Salem Research — Winston-Salem, North Carolina, United States (enrolling)
- Temple University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- Segal Institute of Clinical Research — Aventura, Florida, United States
- University of Oklahoma — Tulsa, Oklahoma, United States
- Discovery Research, Inc. — Plantation, Florida, United States
- Atlanta Women's Research Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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