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

NCT06530186 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-07-31

No results posted yet for this study

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.

Conditions

  • Vaginal Infection
  • Vaginal Discharge
  • Vaginosis
  • Sexual Dysfunction

Interventions

DEVICE

LiviWell Postcoital Vaginal Insert

subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06530186 on ClinicalTrials.gov