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

NCT04664985 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-03

No results posted yet for this study

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 women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.

Conditions

  • Vaginal Disease

Interventions

DEVICE

Mucogyne® ovule

hyaluronic acid, vaginal ovule

Sponsors & Collaborators

  • Créapharm

    collaborator UNKNOWN

  • Institut Alfred Fournier

    collaborator UNKNOWN

  • Axonal-Biostatem

    collaborator INDUSTRY

  • Laboratoires IPRAD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2022-08-31
Completion
2023-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04664985 on ClinicalTrials.gov