Clinical trial · Interventional
Laser Therapy for Vulvovaginal Symptoms in Breast Cancer Patients
NCT03628092CI-TRIAL-00043967LAAVA2unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To determine the efficacy of ablative carbon dioxide laser in the treatment of the signs and symptoms of vulvovaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM) in women with breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genitourinary Symptoms and Ill-Defined Conditions | — | UNRESOLVED | — |
| Vulvovaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO2 Fractional Ablative Laser | Device | — | UNRESOLVED |
| Placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CO2 Fractional Ablative Laser
- description
- 3 treatments approximately 4 weeks apart with vaginal/vulval laser
- interventionNames
- Device: CO2 Fractional Ablative Laser
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 3 treatments approximately 4 weeks apart with "sham" laser
- interventionNames
- Device: Placebo
Primary outcomes (1)
- measure
- Vaginal dryness
- timeFrame
- 12 weeks after completion of treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with a history of early breast cancer \>18 years of age * At baseline patients must have at least one of five symptoms rated at ≥5 on a 10cm VAS scale. Symptoms include vulvo-vaginal itch, dryness, burning, dysuria and dyspareunia. * Three groups of patients will qualify: * Treatment induced premature menopause ≤45 years of age (eg secondary to chemotherapy or oophorectomy) for \>6 months * Premenopausal women on GNRH (gonadotrophin releasing hormone) agonist + tamoxifen or an aromatase inhibitor * Postmenopausal women on tamoxifen or an aromatase inhibitor * Willingness to give written informed consent and willingness to comply with the study * Up to date pap test / HPV (human papillomavirus) testing Exclusion Criteria: * Medical contraindication to the use of fractional ablative CO2 laser * Use of oestrogen therapies (systemic or local) in the 6 weeks prior to study treatment * Use of vaginal lubricants or moisturisers 14 days prior to the study treatment * Active or recent genitourinary infections (\<30 days) * Genital prolapse (grade III) * Active or symptomatic vulvo-vaginal dermatological conditions (Lichen sclerosus, lichen planus, vulval psoriasis, Chron's disease, Hidradenitis Suppurativa, vulval dermatitis, candida, chronic vulvovaginal candidiasis, vulval intraepithelial neoplasia, genital warts) * Inability to tolerate the use of fractional ablative CO2 laser (eg vaginismus)
References
Publications (0)
Data not yet available
No reference posted for this study.