NCT06828640 Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
| NCT ID | NCT06828640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre |
| Condition | Vulvo Vaginal Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-10-16 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-10-16 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse). Statistical Analysis: Differences at baseline, 4 weeks, and 12 weeks will be tested using: Two-sample t-test Mann-Whitney test Statistical Power: Assuming a 20% improvement in Group 1 and 40% in Group 2, with: p \< 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups. SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy
Eligibility 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.
Contact & Investigator
Serge Rozenberg, Gynaecologist
STUDY DIRECTOR
Saint Pierre University Hospital Center
Frequently Asked Questions
Who can join the NCT06828640 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Vulvo Vaginal Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828640 currently recruiting?
Yes, NCT06828640 is actively recruiting participants. Contact the research team at julie.piral@ulb.be for enrollment information.
Where is the NCT06828640 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06828640 clinical trial?
NCT06828640 is sponsored by Centre Hospitalier Universitaire Saint Pierre. The principal investigator is Serge Rozenberg, Gynaecologist at Saint Pierre University Hospital Center. The trial plans to enroll 160 participants.