Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Status unconfirmed · Not applicable
Conditions studied: Vaginal Discharge, Dyspareunia, Female Sexual Dysfunction, Vaginitis, Bacterial Vaginoses
In brief
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.
Key facts
- Study ID
- NCT04885556
- Run by
- Atlantic Health System
- People needed
- 30
- Starts
- 2021-04-05
- Expected to finish
- 2021-09-15
- Last updated by the study team
- 2021-05-13
Who can join
Age: 25 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Heterosexual
- Age 25-50
- Has used tampons in the past 5 years
- Sexually active (vaginal intercourse, minimum once per week)
- Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day"
- Willing and able to use product
- Understands, reads, writes, and speaks English
You may not qualify if…
- Pregnant
- Currently using condoms
- Unable to use device due to poor motor function
- Chronic disease which makes prone to infection (diabetes, autoimmune)
- Recurrent yeast infections
- Recurrent Urinary tract infection (UTI) (>2 within the past year)
- Diagnosis of pelvic organ prolapse (Stage II or greater)
- Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product
- Unable to sign informed consent
Where it is running
- The Center for Specialized Women's Health, division of Garden State Urology — Denville, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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