Status:
RECRUITING
Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
MATMATECH
Conditions:
Vaginal Dryness
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
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 r...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06900374
Start Date
June 15 2025
End Date
June 1 2028
Last Update
September 26 2025
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020