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| Sponsored by: |
Abbott Research Group |
|---|---|
| Information provided by: | Abbott Research Group |
| ClinicalTrials.gov Identifier: | NCT00417365 |
Purpose
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
| Condition | Intervention |
|---|---|
|
Vaginal Odor |
Device: WaterWorks Douching Device |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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" |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | September 2007 |
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 infection, bacterial vaginosis, trichomoniasis, or vulvovaginal candidiasis. However, investigators suggest that there is a large population of women who complain of odor with or without complaints of discharge, and in whom no clear cause can be found. For these women, there are currently no treatment options. Anecdotal evidence suggests that stainless steel used with just water has an effect in reducing odors and is so used to reduce odors on hands by chefs.
The Water Works® Douching Device is a light-weight (1oz) stainless steel douching device that was developed to aid in the treatment of vaginal odor.
Additional anecdotal evidence suggests that douching with the Water Works® Douching Device had little or no affect on the vaginal Eco-System (e.g. good bacteria, Lactobacilli). This study (ARG105B) will compare the Water Works® Douching Device to a commercially available over the counter douching device for the ability to reduce or eliminate abnormal odor (with or without complaints of discharge) in women with this subjective complaint, but no objective findings of a vaginal infection. The study will also compare the Water Works® Douching Device to the commercial device with respect to the adverse effect of the vaginal Eco-System.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Enrollment in the study will be open to those subjects who meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the enrollment if they have any of the following:
Contacts and Locations| United States, Florida | |
| Segal Institute of Clinical Research | Completed |
| Aventura, Florida, United States, 33161 | |
| Discovery Research, Inc. | Withdrawn |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Atlanta Women's Research Institute | Active, not recruiting |
| Atlanta, Georgia, United States, 30342 | |
| United States, Michigan | |
| Wayne State University, Harper Hospital | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Debbie Leaman 313-577-5296 dleaman@med.wayne.edu | |
| Principal Investigator: Jack Sobel, M.D. | |
| United States, North Carolina | |
| Salem Research | Recruiting |
| Winston Salem, North Carolina, United States, 27103 | |
| Contact: Adrianna Fulda 336-760-3909 afulda@salemresearch.com | |
| Contact: Patricia Creed (336) 760-3909 pcreed@salemresearch.com | |
| Principal Investigator: Thomas Valaoras, M.D. | |
| United States, Oklahoma | |
| University of Oklahoma | Terminated |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Temple University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Sarminia Hassan, M.D. 215-707-7278 shassan@temple.edu | |
| Principal Investigator: Ashwin Chatwni, M.D. | |
| Principal Investigator: | Ashwin Chatwani, M.D. | Temple University |
| Principal Investigator: | Jack Sobel, M.D. | Wayne State University |
More Information
| Study ID Numbers: | ARG105B, Pre-IDE I060071 |
| Study First Received: | December 28, 2006 |
| Last Updated: | August 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00417365 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
odor douching BV vaginitis vaginal |
yeast ecosystem Lactobacilli Nugent Amsel |
|
Genital Diseases, Female Vaginitis Vaginal Diseases Acidophilus |
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Genital Diseases, Female Vaginitis Vaginal Diseases |