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

Vaginal Disease Clinical Trial

— HYDRAMUC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04664985
• Other study ID #: IPR_HYDRAMUC_17
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: December 2021
• Source: Laboratoires IPRAD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms
• Vaginal Disease
• Vaginal Diseases

Intervention

Device:
• Mucogyne® ovule
hyaluronic acid, vaginal ovule

Locations

Country	Name	City	State
France	Chru Besancon - Site 002	Besançon
France	Leon Berard - Site 007	Lyon
France	Institut de Cancerologie de Lorraine - Site 004	Nancy
France	Chu Nantes - Site 003	Nantes
France	Chu Caremeau - Site 001	Nîmes
France	Clinique Pasteur - Site 005	Toulouse
France	Institut Gustave Roussy - Site 006	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
Laboratoires IPRAD	Axonal-Biostatem, Créapharm, Institut Alfred Fournier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to additional local treatment administration		3 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	Vaginal flora composition (Nugent score) evolution	Measured on vaginal sample collected at inclusion, 1 month and 3 months	3 Months
Secondary	Complications and adverse events	Complications and adverse events related to study intervention	3 Months
Secondary	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