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Life sciences · Interventional Study
ClinicalTrials.gov · September 29, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05585476). This is a study registration, not published results. Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 195 participants (ESTIMATED). Conditions: Female Urogenital Diseases, Breast Cancer Female. Interventions: DEVICE: C02 microablative laser; COMBINATION_PRODUCT: Regenerative topical treatment. Primary outcome measures: Presence of symptoms at the vulvovaginal level and their intensity , From prior consultation at the beginning of treatment to 6 months after it ends.. Brief 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.