Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters

Part of paid clinical trials in Mountain Lakes, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06530186
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Sexual Dysfunction
  • Vaginal Discharge
  • Vaginal Infection
  • Vaginosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • LiviWell Postcoital Vaginal Insert — DEVICE
    subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

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

Primary Outcome Measure

User Experience Questionnaire [ Time Frame: 24 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Garden State UrologyMountain LakesNew Jersey07046
Cathy Smith, MA
[email protected]
973-537-5557
Michael Ingber, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Mountain Lakes, NJ

By research site
Garden State Urology· Mountain Lakes, NJ

Related Studies