About this trial
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
Qualifiers
Patients over 18 years of age
Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy.
That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index<ó=15).
That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points).
Disqualifiers
Medical or surgical history that at the discretion of the researcher does not allow participation in the study.
Refusal to participate in the study and to sign consent.
Be on chemotherapy treatment at the time of inclusion in the study.
Have completely completed the adjuvant hormonal treatment.
Trial design
Treatments tested in this trial
- C02 microablative laser
- Regenerative topical treatment
Treatment groups
Locations
Sponsors and collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Lead sponsor
Lumenis Be Ltd.
Collaborator
Mucosa Innovations, S.L.
Collaborator