Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients (RF-Vaginale)

March 16, 2026 updated by: Centre Oscar Lambret

RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer

This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.

Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:

The first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.

The second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer.

The participants are divided into two groups:

One group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. If needed, they can also use other supportive treatments like physiotherapy or vaginal dilators.

The other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart.

After six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA :

  • Patient over 40 years
  • Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
  • Patient undergoing adjuvant treatment for breast cancer
  • Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
  • Patient affiliated to a social security organization
  • Patient having signed the informed consent for the present study

EXCLUSION CRITERIA:

  • Contraindications related to the radiofrequency technique:

    • Ongoing urinary tract infection
    • Pacemaker
    • IUD intrauterine device
    • Pregnancy
  • Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
  • Neurodegenerative disease with perineal involvement
  • Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
  • Pregnant or breast-feeding women
  • Patients under guardianship or trusteeship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal radiofrequency treatment

The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6).

The blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved.
Device: GynWave-360

For patients randomized to the experimental group:

3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +/- 1 maintenance session between 8 and 12 months after the first session (M8-12).

Other: Local hydratation
Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).
Active Comparator: Reference treatment
Local hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling).
Other: Local hydratation
Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical scale for vaginal dryness according to patient
Time Frame: The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).
Patient-rated 0-10 Numerical Rating Scale for vaginal dryness, minimum value =0; maximum value = 10; where 0 = No dryness and 10 = Maximum possible dryness.
The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Rated 0-10 numerical scale for dyspareunia
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Patient-rated 0-10 numerical rating scale for dyspareunia, minimum value = 0; maximum value = 10; where 0 = No pain during intercourse and 10 = Maximum possible pain
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal elasticity score
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Vaginal elasticity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

  1. = None
  2. = Poor
  3. = Fair
  4. = Good
  5. = Excellent

Higher scores indicate better vaginal elasticity.
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal fluid volume score
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Vaginal fluid volume is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

  1. = None
  2. = Scar amount (vault not entirely covered)
  3. = Superficial amount (vault entirely covered)
  4. = Moderate amount
  5. = Normal amount Higher scores indicate greater fluid volume, which reflects better vaginal hydration.
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS) : vaginal pH measurement
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Vaginal pH is measured using a pH test strip applied to the vaginal mucosa by a physician observer. The pH is categorized as follows:

  1. = ≥6.1
  2. = 5.6-6.0
  3. = 5.1-5.5
  4. = 4.7-5.0
  5. = ≤4.6 Lower values indicate a healthier vaginal environment.
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal epithelial integrity score
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Epithelial integrity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

  1. = Petechiae noted before contact
  2. = Bleeds with light contact
  3. = Bleeds with scraping
  4. = Not friable (thin epithelium)
  5. = Normal Higher scores indicate better vaginal epithelial integrity.
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Vaginal Health Index Score (VHIS): vaginal moisture score
Time Frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Vaginal moisture is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

  1. = None (surface inflamed)
  2. = None (surface non-inflamed)
  3. = Minimal
  4. = Moderate
  5. = Normal Higher scores indicate better vaginal moisture levels.
baseline (M0), 3, 6 and 12 months (M3, M6, M12)
Side effects of radiofrequency treatment
Time Frame: through study completion: 12 months

Type of side effects : sensation of heat, redness, erythema, hypersensitivity, dyspareunia, other.

Time of onset : during the session, immediately after, or more than 24 hours after the session.

Intensity : graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), with scores ranging from Grade 1 (mild) to Grade 5 (death). Higher scores indicate greater severity of adverse effects.

Consequences for the treatment: need to interrupt the session, reduce the radiofrequency temperature, etc.
through study completion: 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of discontinuation or modification of hormone therapy
Time Frame: through study completion: 12 months
- At each follow-up visit 3 months, 6 months, 12 months post-randomization : data collection on any discontinuation of initially prescribed hormone therapy, change of hormone therapy, other changes in treatment, and reasons for these changes.
through study completion: 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

MATMATECH

Investigators

  • Study Director: Julie DEMETZ, MD, Centre Oscar Lambret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-Vaginale-2401
  • 2024-A01126-41 (Other Identifier: ANSM)
  • API-23-18 (Other Grant/Funding Number: DGOS/INCA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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