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

Not Applicable

• Conditions: Vaginal Disease
• Interventions: Device: Mucogyne® ovule

• Registration Number: NCT04664985
• Lead Sponsor: Laboratoires IPRAD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03
• Primary Completion: 2022-08-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mucogyne®	Mucogyne® ovule	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.

Primary Outcome Measures

Name	Time	Method
Vaginal Health Index (VHI) change from inclusion to end of study	3 Months	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)

Secondary Outcome Measures

Name	Time	Method
Vaginal flora composition (Nugent score) evolution	3 Months	Measured on vaginal sample collected at inclusion, 1 month and 3 months
Vaginal mucosa scarring evolution	3 Months	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)
Time to additional local treatment administration	3 Months
Complications and adverse events	3 Months	Complications and adverse events related to study intervention
Patient Global Impression of Change (PGIC) on vaginal health	3 Months	Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention
Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution	3 Months	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)
VHI change at each visit	3 Months	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)
Patient satisfaction questionnaire at the end of study	3 Months	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"

Trial Locations

Locations (7)

Chu Nantes - Site 003; 🇫🇷 Nantes, France

Chu Caremeau - Site 001; 🇫🇷 Nîmes, France

Clinique Pasteur - Site 005; 🇫🇷 Toulouse, France

Institut Gustave Roussy - Site 006; 🇫🇷 Villejuif, France

Chru Besancon - Site 002; 🇫🇷 Besançon, France

Leon Berard - Site 007; 🇫🇷 Lyon, France

Institut de Cancerologie de Lorraine - Site 004; 🇫🇷 Nancy, France