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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE SAINT PIERRE · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective a vaginal dilator is when added to the usual treatments for vulvovaginal atrophy (VVA), a condition that can cause discomfort and dryness in the vaginal area, particularly in peri- and postmenopausal women and breast cancer survivors. The trial will compare two groups: one group will receive standard care, which includes hormonal therapy and moisturizers, while the other group will receive the same standard care plus a silicone vaginal dilator that helps gradually stretch the vaginal tissues. Researchers will measure the severity of VVA symptoms, pain during intercourse, and overall vaginal health at the start of the study, and again at 4 and 12 weeks.

To participate in this trial, women must be peri- or postmenopausal and experiencing symptoms of VVA. Breast cancer survivors with these symptoms are also eligible. Participants will need to understand the study and agree to take part by signing a consent form. They may use certain estrogen or progestogen treatments, but this will be noted during the study's randomization process. The trial is currently recruiting, and participants can expect regular assessments of their symptoms and overall vaginal health throughout the study period.

Gender

FEMALE

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.