Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00417365|
Recruitment Status : Unknown
Verified August 2007 by Abbott Research Group.
Recruitment status was: Recruiting
First Posted : January 1, 2007
Last Update Posted : August 15, 2007
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Odor||Device: WaterWorks Douching Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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"|
|Study Start Date :||August 2006|
|Estimated Study Completion Date :||September 2007|
- The primary endpoint of the study is the reduction or abatement of the
- subject's perceived vaginal odor as determined at Visit 3.
- This improvement will be measured using a visual analog scale that
- asks subjects to rate their perception of vaginal odor on a scale that
- is anchored at two extremes, "no odor", and, "strong offensive odor".
- Effects on the vaginal Eco-System will be assessed using the
- Lactobacilli score and the Nugent score. The safety profile of the douching
- device (Water Works® versus control) will be assessed through the collection
- of any reported adverse events. Any adverse event, will be reported in terms
- of severity, relationship to treatment, duration, and resolution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417365
|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 email@example.com|
|Principal Investigator: Jack Sobel, M.D.|
|United States, North Carolina|
|Winston Salem, North Carolina, United States, 27103|
|Contact: Adrianna Fulda 336-760-3909 firstname.lastname@example.org|
|Contact: Patricia Creed (336) 760-3909 email@example.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 firstname.lastname@example.org|
|Principal Investigator: Ashwin Chatwni, M.D.|
|Principal Investigator:||Ashwin Chatwani, M.D.||Temple University|
|Principal Investigator:||Jack Sobel, M.D.||Wayne State University|