Status:
UNKNOWN
Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
Lead Sponsor:
Abbott Research Group
Conditions:
Vaginal Odor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
Detailed Description
Vaginal symptoms, including abnormal odor with or without complaints of discharge, are relatively common complaints. It is generally assumed that most women with these complaints have a vaginal infect...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00417365
Start Date
August 1 2006
End Date
September 1 2007
Last Update
August 15 2007
Active Locations (7)
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1
Segal Institute of Clinical Research
Aventura, Florida, United States, 33161
2
Discovery Research, Inc.
Plantation, Florida, United States, 33324
3
Atlanta Women's Research Institute
Atlanta, Georgia, United States, 30342
4
Wayne State University, Harper Hospital
Detroit, Michigan, United States, 48201