Clinical trial · Interventional
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
NCT04664985CI-TRIAL-00055747HYDRAMUCunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vaginal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mucogyne® ovule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Mucogyne®
- description
- The dosage during the study will be 1 Mucogyne® ovule per day at bedtime for 10 days and then 1 ovule every 2 days until the end of the 3-month follow-up.
- interventionNames
- Device: Mucogyne® ovule
- type
- NO_INTERVENTION
- label
- Control
- description
- No treatment for this arm.
Primary outcomes (1)
- measure
- Vaginal Health Index (VHI) change from inclusion to end of study
- timeFrame
- 3 Months
- description
- Each parameter is evaluated from 1 (worst) to 5 (best/normal): * vaginal elasticity, * vaginal secretion volume, * vaginal pH, * epithelial mucous membrane integrity, * vaginal hydration/lubrication. The sum of points for each parameter gives the VHI, from 5 (worst) to 25 (best/normal)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.