Status:
UNKNOWN
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Lead Sponsor:
Laboratoires IPRAD
Collaborating Sponsors:
Créapharm
Institut Alfred Fournier
Conditions:
Vaginal Disease
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief Summary
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 wo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04664985
Start Date
October 6 2020
End Date
January 31 2023
Last Update
January 3 2022
Active Locations (7)
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1
Chru Besancon - Site 002
Besançon, France, 25000
2
Leon Berard - Site 007
Lyon, France, 69373
3
Institut de Cancerologie de Lorraine - Site 004
Nancy, France, 54519
4
Chu Nantes - Site 003
Nantes, France, 44093