Postcoital Sponge for Vaginal Health

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Atlantic Health System

Disqualifiers: Pregnancy, Poor motor function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

I am sexually active with men.

Resides in continental USA

Exclusion Criteria

Currently pregnant or trying to conceive

I have difficulty using devices due to poor hand movement.

I am unable to understand or sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Livi device post-coitally and provide feedback on user experience and changes in vaginal pH

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in vaginal health parameters and user experience feedback

1 week

Treatment Details

Interventions

• LiviWell Postcoital Vaginal Insert

Trial Overview 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.

Participant Groups

Group I: pH subset Experimental Treatment 1 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 Cohort Experimental Treatment 1 Intervention

This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH

Who Is Running the Clinical Trial?

Atlantic Health System

Lead Sponsor

Trials

58

Recruited

9,400+