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NCT05585476
A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Conditions: Female Urogenital Diseases, Breast Cancer Female
Sex: Female
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 195
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Location: Hospital Universitario Fundación Jiménez Díaz Madrid
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.
Eligibility Criteria
Inclusion Criteria:
Patients must meet ALL of the following criteria to be included in the study:
1. Patients over 18 years of age
2. Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy.
3. That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index\
Source: ClinicalTrials.gov (NCT05585476). StuddyBuddy aggregates publicly available trial information.