Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.

Inclusion Criteria:

• Woman over 18
• hysterectomized patient with endometrial cancer (stage I, stage II and histological type I, without chemotherapy, with brachytherapy and/or radiotherapy) OR patient with cervical cancer (stage IA2 and IB1 with emboli or positive lymphadenopathy and IB2 stages with or without chemotherapy, with brachytherapy and / or radiotherapy)
• Only for patients with cervical cancer, premenopausal and non-hysterectomized: patient on contraception at least one month before V0 and throughout the study
• Only for patients with cervical cancer: complete remission
• Patient capable of receiving and understanding information related to the study, giving informed written consent, and easily completing a quality of life questionnaire
• Patient affiliated to the French social security system

Exclusion Criteria:

• Patient with clinically observed vulvovaginal infections
• Patient with endometrial cancer treated with chemotherapy
• Patient already participating in another study
• Patient under legal protection, or under guardianship or curatorship
• Only for patients with cervical cancer: local treatment with estrogen
• Only for patients with cervical cancer, premenopausal and non-hysterectomized: pregnancy (pregnancy test to be performed at V0)