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 | Completed

• 1 other identifier: RP-VAGIFIL-2021
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the performance of Vaginal Filler in improving sexual functions.

  The Female Sexual Function Index (FSFI) will be used to evaluate the improvement of sexual functions at the end-of-study visit, comparing the results between the treatment and the control group. This questionnaire consists of 19 questions addressed to the patient, who can answer with a score from 0 or 1 (worst result) to 5 (best result).

  At the end of the study (Visit V4) 6 months after enrolment.

Secondary Outcomes (13)

• Evaluation of the performance of Vaginal Filler in improving sexual functions.

  At V0 (Baseline visit day 0, before IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).

• Evaluation of the performance of Vaginal Filler in improving subjects' quality of life.

  At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).

• Evaluation of the performance of Vaginal Filler in improving the shape and re-proportioning the ratio between labia minora and labia majora.

  At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).

• Evaluation of the performance of Vaginal Filler for vulvar reshaping.

  At V0 (Baseline visit day 0, before and after IP administration), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).

• Evaluation of the performance of Vaginal Filler to alleviate the symptoms of vulvar atrophy and hypotrophy.

  At V0 (Baseline visit day 0), V1 (2 weeks from V0), V2 (1 month from V0), V3 (3 months from V0) and V4 (6 months from V0).

Study Arms (2)

Treatment Group (Vaginal Filler)

EXPERIMENTAL

Considering a drop out rate of 10%, 76 female subjects (38 patients per group) will be enrolled. Subjects will be randomly assigned to one of the two arms with a 1:1 ratio: 38 subjects will receive the investigational product, the control group will consist of 38 untreated subjects. If assigned to the Vaginal Filler treatment group, participants will be administered the Vaginal Filler device via microinjections into the labia majora. Vaginal Filler is a resorbable medical device (physiological, apyrogenic, sterile gel) to be used as a filler to correct hypotrophy, improve the shape and increase the volume of the female external genital areas (labia majora). The main component is cross-linked hyaluronic acid of non-animal origin, produced by bacterial fermentation cross-linked with 1,4-butanediol diglycidyl ether (BDDE).

Device: Injections of a filler gel containing cross-linked hyaluronic acid

Control Group

NO INTERVENTION

Considering a drop out rate of 10%, 76 female subjects (38 patients per group) will be enrolled. Subjects will be randomly assigned to one of the two arms with a 1:1 ratio: 38 subjects will receive the investigational product, the control group will consist of 38 untreated subjects. 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.

Interventions

Injections of a filler gel containing cross-linked hyaluronic acid DEVICE

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.

Treatment Group (Vaginal Filler)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects Informed consent form (ICF) signed;
• Female aged 40-65 years;
• Atrophy and/or hypotrophy of labra majora requiring volume augmentation. Hypotrophy will be preoperatively staged in mild, moderate and severe considering both the adipose tissue and the cutaneous layer;
• Body Mass Index (BMI)\<32 Kg/m2;
• Willingness to follow all study procedures, including attending all site visits, tests and examinations.

You may not qualify if:

• Allergy or controindications to device components;
• Allergy or controindications to anesthetic components;
• Previous surgery on external genitalia;
• Infectious or inflammatory processes close to the area of the procedure;
• History of vulvar cancer (including vulvar squamous papillomas) and/or previous regional radiotherapy;
• Active local herpes simplex or herpes zoster infection;
• Active herpes zoster infection in other sites;
• Active skin allergy including local dermatitis;
• Chronic pathological skin condition;
• Active mycosis and others bacterial infections;
• Immune system illnesses/disease;
• Known hypersensitivity to cheloids;
• Diabetes mellitus or uncontrolled systemic diseases (endocrine, hepatic renal, cardiac, pulmonary, neurological disorder);
• Problems with coagulation or anti-coagulating therapies in progress;
• Current treatment with substances which act on blood fluidity (eg. Aspirin, NSAIDs, Vitamin C), anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago), drugs able to influence the test results in the investigator opinion;

Sponsors & Collaborators

• Rose Pharma SA: lead
• 1Med: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele di Milano

Milan, Milan, 20132, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 76 subjects are enrolled and randomly assigned to one of the two arms with a 1:1 ratio. 38 subjects will receive the investigational product Vaginal Filler according to the Instruction For Use (IFU); the control group will consist of 38 untreated subjects.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 28, 2025
• Study Start: April 8, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)