Vulvo Vaginal Atrophy

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Review clinical trials related to Vulvo Vaginal Atrophy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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 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

Participants needed: 160
Trial details
Age: 18-85Biological sex: FemaleType: InterventionalSponsor: Centre Hospitalier Universitaire Saint PierreUpdated: Feb 14, 2025Locations: 1
Eligibility criteria

Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA) [+3]

Undiagnosed abnormal genital bleeding. [+8]