Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment

This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. Study Population: Peri- and postmenopausal women with VVA, including breast cancer survivors. Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes. Procedures: Assessments at baseline, at 4 \& 12 weeks Measures : Vulvo V

Trial Details

NCT ID
NCT06828640
Phase
NA
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • vaginal dilators
Locations (sample)
  • Brussels, Brussels Capital, Belgium|50.85045,4.34878

Key Eligibility Criteria

  • Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
  • Breast cancer survivors with VVA symptoms
  • Understand the study, be willing to participate, and sign an informed consent form.
  • The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be consid…

For full eligibility, visit ClinicalTrials.gov.

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