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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. (HYDRAMUC)

Primary Purpose

Vaginal Disease

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mucogyne® ovule
Sponsored by
Laboratoires IPRAD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Disease focused on measuring vaginal dryness

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Chru Besancon - Site 002
  • Leon Berard - Site 007
  • Institut de Cancerologie de Lorraine - Site 004
  • Chu Nantes - Site 003
  • Chu Caremeau - Site 001
  • Clinique Pasteur - Site 005
  • Institut Gustave Roussy - Site 006

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mucogyne®

Control

Arm Description

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.

No treatment for this arm.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Time to additional local treatment administration
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
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)
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)
Vaginal flora composition (Nugent score) evolution
Measured on vaginal sample collected at inclusion, 1 month and 3 months
Complications and adverse events
Complications and adverse events related to study intervention
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"

Full Information

First Posted
November 18, 2020
Last Updated
December 13, 2021
Sponsor
Laboratoires IPRAD
Collaborators
Créapharm, Institut Alfred Fournier, Axonal-Biostatem
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1. Study Identification

Unique Protocol Identification Number
NCT04664985
Brief Title
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Acronym
HYDRAMUC
Official Title
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires IPRAD
Collaborators
Créapharm, Institut Alfred Fournier, Axonal-Biostatem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Disease
Keywords
vaginal dryness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mucogyne®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment for this arm.
Intervention Type
Device
Intervention Name(s)
Mucogyne® ovule
Intervention Description
hyaluronic acid, vaginal ovule
Primary Outcome Measure Information:
Title
Vaginal Health Index (VHI) change from inclusion to end of study
Description
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)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Vaginal mucosa scarring evolution
Description
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 Frame
3 Months
Title
Time to additional local treatment administration
Time Frame
3 Months
Title
Patient Global Impression of Change (PGIC) on vaginal health
Description
Auto-evaluation: score from 1 (very much improved) to 7 (very much worse) on vaginal health related to the study intervention
Time Frame
3 Months
Title
Symptoms (pain, dyspareunia, vaginal pruritis, vulvovaginal dryness) evolution
Description
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)
Time Frame
3 Months
Title
VHI change at each visit
Description
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)
Time Frame
3 Months
Title
Vaginal flora composition (Nugent score) evolution
Description
Measured on vaginal sample collected at inclusion, 1 month and 3 months
Time Frame
3 Months
Title
Complications and adverse events
Description
Complications and adverse events related to study intervention
Time Frame
3 Months
Title
Patient satisfaction questionnaire at the end of study
Description
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"
Time Frame
3 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Chru Besancon - Site 002
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
Leon Berard - Site 007
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut de Cancerologie de Lorraine - Site 004
City
Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Chu Nantes - Site 003
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Chu Caremeau - Site 001
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Clinique Pasteur - Site 005
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Institut Gustave Roussy - Site 006
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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