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Behavioural Intervention

Postcoital Sponge for Vaginal Health

N/A
Waitlist Available
Research Sponsored by Atlantic Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually-active with biological men
Be older than 18 years old
Must not have
Unable to use device due to poor motor function
Unable to sign informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-6 hours, and 10-14 hours after use
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a product called Livi, which is designed to quickly absorb semen after sex. Previous studies have shown that using Livi can reduce symptoms like vaginal odor and discharge. This new

Who is the study for?
This trial is for individuals experiencing sexual dysfunction, vaginal infections, bacterial vaginosis, or unusual vaginal discharge. Participants should be interested in testing a postcoital sponge designed to absorb semen and potentially reduce symptoms like odor and discharge after sex.
What is being tested?
The LiviWell Postcoital Vaginal Insert is being tested for its effectiveness in absorbing semen after intercourse and improving symptoms related to the vaginal microbiome disruption such as odor and discharge.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort during use, allergic reactions to the insert material, or an imbalance in normal vaginal flora leading to irritation or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am sexually active with men.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have difficulty using devices due to poor hand movement.
Select...
I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-6 hours, and 10-14 hours after use
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 hours, and 10-14 hours after use for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
User Experience Questionnaire
Secondary study objectives
change in vaginal pH

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: pH subsetExperimental Treatment1 Intervention
This subset of patients (n=100) will be checking their vaginal pH at various time intervals (before, 2-6 hours after, and 10-14 hours after sex).
Group II: Main CohortExperimental Treatment1 Intervention
This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH

Find a Location

Who is running the clinical trial?

Atlantic Health SystemLead Sponsor
54 Previous Clinical Trials
6,537 Total Patients Enrolled
~500 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
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