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Completed

NCT Number: NCT07445958

In-Clinic Assessment of Vaginal Mucosal Safety Following Repetitive Use of the Livi Device

The goal of this clinical trial is to learn if the Livi postcoital tampon device is safe for repetitive use in sexually active women aged 18 years and older. The main question it aims to answer is:

Does using the Livi device three times in a row cause any visible vaginal mucosal trauma? How much pain or discomfort do participants experience during insertion and removal?

Researchers will not compare the Livi device to another product because this is a single-arm safety study.

Participants will:

* Insert and remove the Livi device three times consecutively during one clinic visit * Undergo a baseline speculum exam and digital colposcopy exams after each device removal to check vaginal tissue * Complete a 24-hour follow-up via e-diary or phone call to report pain, spotting, or other symptoms * Report any unsolicited symptoms for 7 days after use

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Key information

Conditions

Vaginal Discharge Behavior Coitus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Postcoital Vaginal Changes Sexual Behavior Urogenital Diseases Vaginal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Garden State Urology

Mountain Lakes, New Jersey, 07046, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sexually active women aged ≥18 years
  • Able and willing to comply with all study procedures
  • Able to provide written informed consent

Exclusion criteria

  • Current pregnancy or within 6 weeks postpartum
  • Symptomatic vaginal infection, lesion, or vulvovaginal discomfort at baseline
  • Known allergy to any component of the study device
  • Pelvic or vaginal surgery within the past 6 weeks
  • Any medical or psychological condition that, in the investigator's opinion, may interfere with participation or safety

Treatment and study plan

Livi Postcoital Tampon Device

Device

Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.

Primary outcomes

  1. Incidence of Grade ≥2 vaginal mucosal trauma

    Time frame: Immediate post-use (within 5 minutes of device removal)

    Incidence of Grade ≥2 vaginal mucosal trauma assessed immediately after device removal via digital colposcopic examination. Mucosal trauma defined as: Grade 2 (Moderate): Abrasion >5 mm or multiple foci totaling >10 mm; pinpoint bleeding stopping spontaneously. Grade 3 (Severe): Laceration or bleeding requiring medical intervention.

Secondary outcomes

  1. Pain/discomfort during insertion/removal

    Time frame: During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr)

    Immediately after device insertion and removal, Numeric Rating Scale (0- no pain to 10- maximum pain) will be self-reported by patient.

  2. Ease of use

    Time frame: During Visit 1 immediately following third device insertion

    Likert scale on ease of overall device use - Very Easy, Easy, Neither Easy Nor Difficult, Difficult, Very Difficult

  3. Spotting or pain within 24 hours post-use

    Time frame: 24-hour (+/- 6hr) follow-up

    self-reported by subject on e-diary or telephone survey

  4. Allergy and Hypersensitivity Responses

    Time frame: after each study device removal, and up to 7 days following visit 1

    Mucosal changes consistent with allergy or hypersensitivity (eg edema, urticaria, swelling, itching) will be documented - this will be both reported subjectively by the patient, and objectively reported by the clinician using digital colposcopy examinations.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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