Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06900374 | NOT YET RECRUITING | Vaginal Dryness

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
Sponsor:

Oscar Lambret Center

Brief Summary:

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.

Condition or disease

Vaginal Dryness

Breast Cancer

Vulvovaginal Atrophy

Intervention/treatment

GynWave-360

Local hydratation

Phase

NA

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
Estimated Enrollment : 75 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2028-05-01
Estimated Study Completion Date : 2028-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Location Details

NCT06900374

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Oscar Lambret Center

Lille, France, 59020