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

NCT06530186 | Not Yet Recruiting FDA Device

• 1 other identifier: AC-005
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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 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

Keywords

vaginal odor; vaginal discharge; postcoital dripping; vaginal microbiome

Outcome Measures

Primary Outcomes (1)

• User Experience Questionnaire

  Validation of User Needs Requirements as well as patient experience

  24 hours

Secondary Outcomes (1)

• change in vaginal pH

  2-6 hours, and 10-14 hours after use

Study Arms (2)

pH subset

EXPERIMENTAL

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).

Device: LiviWell Postcoital Vaginal Insert

Main Cohort

EXPERIMENTAL

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

Device: LiviWell Postcoital Vaginal Insert

Interventions

LiviWell Postcoital Vaginal Insert DEVICE

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

Also known as: Livi

Main Cohort; pH subset

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: No. Subjects must be biological females at birth in order to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Garden State Urology

Mountain Lakes, New Jersey, 07046, United States

Location

MeSH Terms

Conditions

Vaginitis; Vaginal Discharge; Vaginal Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)