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RECRUITINGNANCT06828640

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...

Lead sponsor: Centre Hospitalier Universitaire Saint Pierre•1 locations•View source on ClinicalTrials.gov

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Contacts

Julie Piral, medical student

CONTACT

+33673428392 julie.piral@ulb.be

Aurélie Joris, gynaecologist

CONTACT

+32 2 535 34 86 aurelie.joris@stpierre-bru.be

Sponsors

Lead Sponsor

Centre Hospitalier Universitaire Saint Pierre

Age

18 - 85 years

Sex

FEMALE

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 14, 2025Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment160

Start dateOct 2024

Last updatedFeb 14, 2025

Condition

Vulvo Vaginal Atrophy Genitourinary Syndrome of Menopause (GSM)Vaginal Atrophy in Breast Cancer Patients Vaginal Atrophy Patients With GSM Treatment+2 more

Locations shown

Saint Pierre University Hospital Center

Brussels, Brussels Capital

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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