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

What this trial studies

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.

Conditions in scope

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

Interventions

• vaginal dilators (Device) — Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors

Who can join

Women only · Ages 18 Years to 85 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2024-10-16
• Primary completion: 2025-10
• Last update posted: 2025-02-14
• First posted: 2025-02-14

Sponsor & contact

Lead sponsor: Centre Hospitalier Universitaire Saint Pierre (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• • Vaginal dryness score (At baseline, 4 and 12 weeks)
  * None: no feeling of dryness. * Mild: occasional feeling of dryness that does not interfere with daily activities. * Moderate: feeling dry most of the time but does not interfere with daily activities. * Severe: continuous feeling of dryness interfering with daily activities.
• • Vaginal and/or vulvar irritation/itching (At baseline, 4 and 12 weeks)
  * None: no feeling of irritation. * Mild: occasional irritating sensation that does not interfere with daily activities. * Moderate: feeling irritated most of the time but does not interfere with daily activities. * Severe: continuous feeling of irritation interfering with daily activities.
• • Pain during sexual intercourse score (At baseline, 4 and 12 weeks)
  * None: pleasant sexual intercourse, rare pain. * Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally. * Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted. * Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due…
• Vaginal Health index score (at baseline and 12 weeks)
  The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina. For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score…
• Patient satisfaction : visual analogue scale (At baseline, 4 and 12 weeks)
  Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms

Related ClearedRx care

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