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EP1101 Efffect of a non-hormonal mucoadhesive polycarbophilic vaginal gel on prevalent vaginal symptoms in women who develop vaginal atrophy

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Introduction/Background Gynecological and breast cancer treatments can cause early ovarian failure with vulvovaginal atrophy (VVA) in the medium-long term. Also, external radiotherapy or brachytherapy for cervix, endometrium or digestive cancer… Click to show full abstract

Introduction/Background Gynecological and breast cancer treatments can cause early ovarian failure with vulvovaginal atrophy (VVA) in the medium-long term. Also, external radiotherapy or brachytherapy for cervix, endometrium or digestive cancer has a potential toxicity risk to develop VVA, loss of elasticity and vaginal stenosis. These changes alter vaginal and sexual health in up to 90% patients. Vaginal moisturizers are recommended periodically in the prevention and treatment of these disorders. Efficacy of a non-hormonal mucoadhesive vaginal gel on symptoms of VVA is evaluated. Methodology 62 women presenting bothering symptoms of VVA (98% with moderate or severe symptoms) received 1g of a mucoadhesive moisturizing vaginal gel daily for 3 weeks (w3) and twice weekly up to 12 weeks (w12). Vaginal dryness (VD), dyspareunia and pruritus were registered at baseline (B), w3 and w12 and symptom intensity was individually scored as 0=absent, 1=mild, 2=moderate, 3=severe. Symptom variation was evaluated as response at w3 and w12 vs B. Patients who improved (change in symptom intensity) and who turned symptom-absent were evaluated. Results All symptoms improved significantly at w3 and w12. VD improved in 71% and 69% of women at w3 (p = 0.01) and w12 (p = 0.02) respectively. Dyspareunia improved in 62% (w3, p < 0.001) and 67% (w12, p < 0.001) of women presenting this symptom, and pruritus improved in 34% (w3, p = 0.03) and 42% (w12, p = 0.008). VD, dyspareunia and pruritus had disappeared in 13%, 22% and 29% of women at w3, and in 21%, 38% and 34% at w12, respectively. Conclusion Discussing vaginal health concerns and treatment options should be considered in the oncologist's regular clinical practice. Management of vulvovaginal symptoms can impact significantly on cancer survivors' quality of life as these symptoms are very prevalent and disturbing. The regular use of this mucoadhesive vaginal gel has proved to be efficacious on this purpose. Disclosure These clinical trials were funded by Italfarmaco S.A. Dr Estévez and Dr Delgado participated as investigators in the clinical trials carried out with this product (EudraCT Numbers: 2007-003399-20 and 2014-004517-84). M.Palma and Dr Nieto are full time employees of Italfarmaco S.A.

Keywords: atrophy; vaginal gel; cancer; non hormonal; gel; hormonal mucoadhesive

Journal Title: International Journal of Gynecological Cancer
Year Published: 2019

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