Clinical Trial

A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.

Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated September 19, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-10-14; most recent amendment 2025-09-15.
Trial Details
NCT Number NCT05585476
Lead Sponsor Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Lumenis Be Ltd., Mucosa Innovations, S.L.
Conditions Female Urogenital Diseases, Breast Cancer Female
Enrollment 180 participants
Start Date 2025-10
Primary Completion 2026-06 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-19