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

Study acronym: RF-Vaginale
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Jun 1, 2028 to Jun 2028
    • Start date: Jun 15, 2025 to Jun 12, 2025
    v7
  2. 2 versions Re-verified since Jul 1, 2025, no change to tracked fieldsv5-v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2025 to Jun 15, 2025
    • Site details revised
    v4
  4. Start date: May 1, 2025 to Jun 1, 2025
    • Primary and study completion dates: May 1, 2028 to Jun 1, 2028
    • Site contact updated
    v3
  5. Secondary endpoints: 3 to 7v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06900374
Lead Sponsor Centre Oscar Lambret
Collaborators: MATMATECH
Conditions
(from sponsor)		 Vaginal Dryness, Breast Cancer, Vulvovaginal Atrophy
Related terms Breast Neoplasms
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov