Clinical trial · Interventional
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspareunia (Female) | — | UNRESOLVED | — |
| Genitourinary Syndrome of Menopause (GSM) | — | UNRESOLVED | — |
| Sexual Disfunction | — | UNRESOLVED | — |
| Treatment | — | UNRESOLVED | — |
| Vaginal Atrophy in Breast Cancer Patients | — | UNRESOLVED | — |
| Vaginal Atrophy Patients With GSM | — | UNRESOLVED | — |
| Vulvo Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vaginal dilators | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group : vaginal dilators
- description
- A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes.
- interventionNames
- Device: vaginal dilators
- type
- NO_INTERVENTION
- label
- Control Group : placebo
- description
- A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers).
Primary outcomes (7)
- measure
- • Vaginal dryness score
- timeFrame
- At baseline, 4 and 12 weeks
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDKingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16. PMID 23679050