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

NCT ID: NCT06530186

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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

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Vaginal Infection Vaginal Discharge Vaginosis Sexual Dysfunction

Keywords

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vaginal odor vaginal discharge postcoital dripping vaginal microbiome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

LiviWell Postcoital Vaginal Insert

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

LiviWell Postcoital Vaginal Insert

Intervention Type DEVICE

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

Interventions

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LiviWell Postcoital Vaginal Insert

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

Intervention Type DEVICE

Other Intervention Names

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Livi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Michael Ingber

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Garden State Urology

Mountain Lakes, New Jersey, United States

Site Status

Countries

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United States

Facility Contacts

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Cathy Smith, MA

Role: primary

Other Identifiers

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AC-005

Identifier Type: -

Identifier Source: org_study_id