Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Atlantic Health System

Conditions:

Vaginal Infection

Vaginal Discharge

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 microb...

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 ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2025

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT06530186

Start Date

August 1 2024

End Date

January 31 2025

Last Update

July 31 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Garden State Urology

Mountain Lakes, New Jersey, United States, 07046