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

Recruiting now · Not applicable

Conditions studied: Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients, Vaginal Atrophy Patients With GSM, Treatment, Sexual Disfunction, Dyspareunia (Female)

In brief

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

Key facts

Study ID

NCT06828640

Run by

Centre Hospitalier Universitaire Saint Pierre

People needed

160

Starts

2024-10-16

Expected to finish

2025-10-01

Last updated by the study team

2025-02-14

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 it is running

• Saint Pierre University Hospital Center — Brussels, Brussels Capital, Belgium (enrolling)

Full record on ClinicalTrials.gov

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