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POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.

NCT06797167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-01-28

No results posted yet for this study

Summary

The overall aim of this research is to gather more information on the effectiveness of the Vaginal Filler medical device used in women to correct the thinning of the external genital tissue of the labia majora, re-proportioning its volume in relation to the labia minora and improving sexual function. It will also collect data about the safety and tolerability of Vaginal Filler.

The main question it aims to answer is:

• Does the treatment with Vaginal Filler medical device lead to an improvement of sexual functions in women with atrophy of female external genitalia (labia major)?

Researchers will compare subjects treated with Vaginal Filler medical device to untreated subjects to better study the effectiveness and also the undesirable effects of Vaginal Filler and to guarantee scientifically valid and bias-free results.

Participants will:

* receive the Vaginal Filler device via microinjections into the labia majora, if assigned to the Vaginal Filler treatment group;
* Attend the clinic for 6 scheduled visits: screening visit (V-1), baseline visit (V0) with the execution of the treatment and 4 subsequent follow-up visits (V1, V2, V3, V4) carried out 2 weeks, 1, 3 and 6 months after V0. The total duration of the study will be approximately 6 months;
* Keep a daily diary of any disorders, health problems or adverse events that may occur;
* Complete some questionnaires during the visits to the clinic.

Conditions

  • Atrophy Vulva

Interventions

DEVICE

Injections of a filler gel containing cross-linked hyaluronic acid

Vaginal Filler will be administered according to Investigator's judgment and Instruction For Use (IFU) to correct hypotrophy, improve the shape and increase the volume of the female external genital areas (labia majora). Vaginal Filler is a resorbable medical device available in packages containing 2 sterile pre-filled mono-use syringes of 1 ml with pre-assembled plunger rod and backstop, containing 25 mg/g cross-linked hyaluronic acid. The injection is performed by medical personnel at visit V0 in one or both sides of the superficial subcutaneous layer of the labia majora, along its longitudinal axis.The dosage to be used for the individual case is at the doctor's discretion. An anesthetic may be applied (lidocaine 2% injection only in the cannula access point) to the affected area before the IP injection. In order to maintain the results achieved, an eventual touch-up could be performed one months after the first treatment in the same areas of the first injection, at visit V2.

Sponsors & Collaborators

  • 1Med

    collaborator OTHER

  • Rose Pharma SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2023-12-23
Completion
2023-12-23

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797167 on ClinicalTrials.gov