Vaginal radiofrequency for vulvovaginal atrophy in people with breast cancer
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
Run by Centre Oscar Lambret · NCT06900374 · Data updated 2026-11-12
This will see if adding three sessions of vaginal radiofrequency to regular hyaluronic acid moisturizer reduces vaginal dryness in women taking aromatase inhibitors for breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 75 (estimated) |
| Sponsor | Centre Oscar Lambret Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | June 12, 2025 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06900374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women over 40 on adjuvant aromatase inhibitor therapy (with or without LHRH agonists) who have persistent, bothersome vaginal dryness despite regular non-hormonal moisturization are the ideal candidates.
✕Probably not a fit
Patients with contraindications to radiofrequency (active UTI, pacemaker, intrauterine device, pregnancy), active vulvovaginal mucocutaneous disease, recent vaginal energy or injectable procedures, or neurodegenerative perineal involvement are unlikely to benefit or cannot participate.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, parallel-group Phase III trial comparing standard non-hormonal vaginal hydration with the same hydration plus three sessions of vaginal radiofrequency given 4–6 weeks apart. Eligible participants are women over 40 receiving adjuvant aromatase inhibitor therapy (with or without LHRH agonists) who have persistent, significant vaginal dryness despite moisturizers. The primary comparison measures symptoms of vaginal dryness at six months after randomization. Supportive measures such as physiotherapy or vaginal dilators may be allowed alongside the moisturizer in both groups.
Why it matters
Potential benefit: If successful, adding vaginal radiofrequency could provide greater relief from vaginal dryness and improve sexual comfort and quality of life for women who cannot use hormonal treatments.
How similar studies have gone: Small uncontrolled and short-term studies of vaginal radiofrequency and other energy-based devices have reported symptom improvements in genitourinary syndrome of menopause, but high-quality randomized evidence—especially in breast cancer patients—is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Centre Oscar Lambret
Lille, France Recruiting
Study contacts
- Study coordinator: Fanny BEN OUNE
- Email: promotion@o-lambret.fr
- Phone: +33320295896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.