NCT06530186

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Vaginal Infection
• Vaginal Discharge
• Vaginosis
• Sexual Dysfunction

Interventions

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

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study