NCT04664985

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

November 18, 2020

Last Update Submit

December 13, 2021

Conditions

Vaginal Disease

Keywords

vaginal dryness

Outcome Measures

Primary Outcomes (1)

  • Vaginal Health Index (VHI) change from inclusion to end of study

    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)

    3 Months

Secondary Outcomes (8)

  • Vaginal mucosa scarring evolution

    3 Months

  • Time to additional local treatment administration

    3 Months

  • Patient Global Impression of Change (PGIC) on vaginal health

    3 Months

  • Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution

    3 Months

  • VHI change at each visit

    3 Months

  • +3 more secondary outcomes

Study Arms (2)

Mucogyne®

ACTIVE COMPARATOR

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.

Device: Mucogyne® ovule

Control

NO INTERVENTION

No treatment for this arm.

Interventions

Mucogyne® ovuleDEVICE

hyaluronic acid, vaginal ovule

Mucogyne®

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chru Besancon - Site 002

Besançon, 25000, France

Location

Leon Berard - Site 007

Lyon, 69373, France

Location

Institut de Cancerologie de Lorraine - Site 004

Nancy, 54519, France

Location

Chu Nantes - Site 003

Nantes, 44093, France

Location

Chu Caremeau - Site 001

Nîmes, 30029, France

Location

Clinique Pasteur - Site 005

Toulouse, 31076, France

Location

Institut Gustave Roussy - Site 006

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 80 women with endometrial cancer or Cervical cancer will be recruited over 8 months, 40 being randomized in the Mucogyne® arm, the 40 others in the control arm.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 11, 2020

Study Start

October 6, 2020

Primary Completion

August 31, 2022

Study Completion

January 31, 2023

Last Updated

January 3, 2022

Record last verified: 2021-12

Locations

FR(7)