Actively Recruiting
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
Led by Centre Hospitalier Universitaire Saint Pierre · Updated on 2025-02-14
160
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) allowed but must be documented
You will not qualify if you...
- Undiagnosed abnormal genital bleeding
- Use of any investigational drug within 30 days prior to screening
- 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
- Disabilities that prevent communication
- Eligible women unwilling to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Saint Pierre University Hospital Center
Brussels, Brussels Capital, Belgium, 1000
Actively Recruiting
Research Team
J
Julie Piral, medical student
CONTACT
A
Aurélie Joris, gynaecologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here