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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Livi Device Safety Evaluation | Experimental | Participants will insert and remove the Livi device three times consecutively during a single clinic visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Livi Postcoital Tampon Device | Device | Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade ≥2 vaginal mucosal trauma | 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. | Immediate post-use (within 5 minutes of device removal) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain/discomfort during insertion/removal | Immediately after device insertion and removal, Numeric Rating Scale (0- no pain to 10- maximum pain) will be self-reported by patient. | During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr) |
| Ease of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden State Urology | Mountain Lakes | New Jersey | 07046 | United States |
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| ID | Term |
|---|---|
| D019522 | Vaginal Discharge |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Likert scale on ease of overall device use - Very Easy, Easy, Neither Easy Nor Difficult, Difficult, Very Difficult |
| During Visit 1 immediately following third device insertion |
| Spotting or pain within 24 hours post-use | self-reported by subject on e-diary or telephone survey | 24-hour (+/- 6hr) follow-up |
| Allergy and Hypersensitivity Responses | 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. | after each study device removal, and up to 7 days following visit 1 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |