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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vaginal Disease
• Intervention / Treatment: Device: Mucogyne® ovule

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Chru Besancon - Site 002
  • Lyon, France, 69373
    • Leon Berard - Site 007
  • Nancy, France, 54519
    • Institut de Cancerologie de Lorraine - Site 004
  • Nantes, France, 44093
    • Chu Nantes - Site 003
  • Nîmes, France, 30029
    • Chu Caremeau - Site 001
  • Toulouse, France, 31076
    • Clinique Pasteur - Site 005
  • Villejuif, France, 94805
    • Institut Gustave Roussy - Site 006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mucogyne®; 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; hyaluronic acid, vaginal ovule
No Intervention: Control; No treatment for this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal mucosa scarring evolution	Evolution of scarring of the vaginal mucosa by a composite score: visualization of the hysterectomy scar (not visible / visible) for endometrial cancer patients OR visualization of the cervix (not visible / visible) for cervical cancer patients,; presence or absence of vaginal adhesions / cohalescences (walls and bottom of the vagina ),; collapse of adhesions to touch (Y / N),; edema / redness of vaginal mucosa (indicative of inflammation),; pain caused by pressure (Y / N),; bleeding caused by contact (none / moderate / severe)	3 Months
Time to additional local treatment administration		3 Months
Patient Global Impression of Change (PGIC) on vaginal health	Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention	3 Months
Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution	Auto-evaluation of the symptoms: pain, dyspareunia, vaginal pruritis, vulvovaginal dryness on Visual Analogic Scale (VAS) of 10mm Patient indicates where she locates the intensity of the symptom from 0mm (no symptom) to 10mm (worst intensity)	3 Months
VHI change at each visit	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 parameters gives the VHI, from 5 (worst) to 25 (best/normal)	3 Months
Vaginal flora composition (Nugent score) evolution	Measured on vaginal sample collected at inclusion, 1 month and 3 months	3 Months
Complications and adverse events	Complications and adverse events related to study intervention	3 Months
Patient satisfaction questionnaire at the end of study	All patients (both arms) will be asked about their satisfaction on the treatment of their vulvogainal symptoms during the study will be assessed using a 5-point Likert scale : "At the end of this study, how would you rate your level of satisfaction with the treatment of your vulvovaginal symptoms? Very satisfactory / Satisfactory / Moderate / Poor / Very Poor"	3 Months

Collaborators and Investigators

• Sponsor: Laboratoires IPRAD
• Collaborators: Creapharm; Institut Alfred Fournier; Axonal-Biostatem

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: vaginal dryness
• Additional Relevant MeSH Terms: Vaginal Diseases
• Other Study ID Numbers: IPR_HYDRAMUC_17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No