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.
Age range
18 Years – 100 Years
Sex
FEMALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Presence of symptoms at the vulvovaginal level and their intensity
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Impact in the quality of life of vulvo-vaginal symptoms.
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Changes in vulvar physical examination
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Changes in vaginal physical examination
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Thickness of the vaginal epithelium
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Quantification of cellular glycogen
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Number of capillaries in vaginal mucosa
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Lactobacillus in vaginal microbiota
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Candida spp in vaginal microbiota
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Gardnerella vaginalis in vaginal microbiota
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Free glycogen detection in vaginal discharge
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Vaginal pH
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Skin elasticity
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of transdermal water in the skin
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Skin pigmentation
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.
Degree of vascularization of the skin
Timeframe: From prior consultation at the beginning of treatment to 24 months after it ends.