Using vaginal dilators to treat vulvo-vaginal atrophy
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
This study is testing if using vaginal dilators along with regular treatment can help peri- and postmenopausal women, including breast cancer survivors, feel better with vulvo-vaginal atrophy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre Academic / other |
| Locations | 1 site (Brussels, Brussels Capital) |
| Trial ID | NCT06828640 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding vaginal dilators to the standard treatment for vulvo-vaginal atrophy (VVA) in peri- and postmenopausal women, including breast cancer survivors. Participants will be randomly assigned to receive either standard care or standard care plus the use of vaginal dilators, which are silicone devices designed for gradual stretching. The study will assess various measures of VVA severity and sexual function at baseline, 4 weeks, and 12 weeks. Statistical analyses will compare outcomes between the two groups to determine the impact of the additional intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are peri- and postmenopausal women experiencing symptoms of vulvo-vaginal atrophy, including breast cancer survivors.
Not a fit: Patients with undiagnosed abnormal genital bleeding, serious medical conditions, or recent vaginal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and sexual health for women suffering from vulvo-vaginal atrophy.
How similar studies have performed: While the use of vaginal dilators is a recognized approach, this specific combination with standard treatment is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 considered during randomization). Exclusion Criteria: * Undiagnosed abnormal genital bleeding. * Administration of any investigational drug within 30 days prior to the screening visit. * Presence of a serious medical condition, neurological disorder, or significant comorbidities. * Other gynecological malignancies. * Recent vaginal surgery. * Clinically significant prolapse (POP-Q ≤ 2). * Current urinary tract or vaginal infection, or recent sexually transmitted infection. * Individuals with disabilities unable to communicate. * Women eligible for the study but unwilling to participate.
Where this trial is running
Brussels, Brussels Capital
- Saint Pierre University Hospital Center — Brussels, Brussels Capital, Belgium (Recruiting)
Study contacts
- Study coordinator: Julie Piral, medical student
- Email: julie.piral@ulb.be
- Phone: +33673428392
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.