Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2021
CompletedFirst Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedMay 13, 2021
May 1, 2021
5 months
April 28, 2021
May 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Global Impression of Improvement (PGI-I)
Validated Questionnaire
within 1 hour of use of product
Weight of Investigational Device
Product weight (amount of fluid absorbed)
within 1 hour of use of product
Study Arms (2)
Immediate Use
EXPERIMENTALSubjects in this arm will be instructed to use the study device for 2 minutes and remove
1 hour use
EXPERIMENTALSubjects in this arm will be instructed to use the product for one hour and then remove
Interventions
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Center for Specialized Women's Health, division of Garden State Urology
Denville, New Jersey, 07834, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 13, 2021
Study Start
April 5, 2021
Primary Completion
September 15, 2021
Study Completion
September 15, 2021
Last Updated
May 13, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share