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

Atlantic Health System

Status: Not yet enrolling

Conditions: Vaginosis; Sexual Dysfunction; Vaginal Discharge; Vaginal Infection

Treatments: Device: LiviWell Postcoital Vaginal Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT06530186

AC-005

Details and patient eligibility

About

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.

Full description

LiviWell's consumer hygiene device is a post-coital vaginal insert called "Livi". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge/dripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH ~4), and semen has an alkaline pH (~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.

The current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over 18 (for pH subset, 18-45)
• Sexually-active with biological men
• Willing and able to use product
• Resides in continental USA
• Understands, reads, writes, and speaks English

Exclusion criteria

• Currently Pregnant or are trying to conceive
• Unable to use device due to poor motor function
• Unable to sign informed consent

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

pH subset

Experimental group

Description:

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).

Treatment:

Device: LiviWell Postcoital Vaginal Insert

Main Cohort

Experimental group

Description:

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

Treatment:

Device: LiviWell Postcoital Vaginal Insert