Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer (HYDRAGYNE)

HYDRAGYNE (MUCG234) - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer

The aim of this post-Market Clinical Follow-up (PMCF) study for a class IIb medical device is to confirm th efficacy and safety of Mucogyne Gel as a moisturizer in women with vaginal dryness irrespective of the cause; when used in accordance with its approved labelling.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Dryness
• Intervention / Treatment: Device: Mucogyne Gel

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roxane NOEL; Phone Number: +33 +33 3 44 86 75 79; Email: r.noel@biocodex.fr

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Dr Paul Lefevre's medical office
    • Contact: Paul LEFEVRE, md
    • Principal Investigator: Paul LEFEVRE, MD
  • Colmar, France, 68000
    • Recruiting
    • Dr Thierry KELLER's medical office
    • Contact: Thierry KELLER, MD
    • Principal Investigator: Thierry KELLER, MD
  • Paris, France, 75018
    • Recruiting
    • Sihame MOKHBAT's office
    • Contact: Sihame MOKHBAT, midwife
    • Principal Investigator: Sihame MOKHBAT, Midwife
  • Écully, France, 69130
    • Recruiting
    • Dr Christiane ARMAND's medical office
    • Contact: Christiane ARMAND, MD
    • Principal Investigator: Christiane ARMAND, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women with the following conditions:

• ≥ 18 years of age at inclusion with vaginal dryness, irrespective of the cause (which may or may not be accompanied by irritation of the vulva, discomfort, or itchiness).
• Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareunia feeling.
• Subject agrees to not use any lubricant, local estrogens, or other vaginal product during the study.
• Subject agrees to not modify their intimate hygiene products.
• Able to understand and sign the informed consent form for study enrolment.
• Subject able to comply with study requirements, as defined in the protocol.
• Subject affiliated to a health social security system.

Exclusion Criteria:

Women with the following conditions:

• General:

  • Pregnancy (subject of childbearing potential must not be pregnant and must agree to avoid pregnancy during the study by using an effective birth control method from at least one month before D0 (V0) and throughout the duration of the study).
  • Participating at the same time in another interventional trial within the four previous weeks and during the study period, being in an exclusion period for a previous study.
  • Deprived of freedom by administrative or legal decision or under guardianship.
  • Subject in a social or sanitary establishment.
  • Subject suspected to be non-compliant according to the investigator's judgment.
  • Subject in an emergency situation.

• Linked to subject's status:

  • Known hypersensitivity to one of MUCOGYNE® Gel components.
  • Subject with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy.

• Linked to previous or ongoing treatments:

  • Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
  • Subject suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results.
  • Subject undergoing a topical treatment on the test area or a systemic treatment: corticosteroids during the 2 previous weeks and during the study; retinoids and/or immunosuppressors during the 1,5 previous months and during the study; subject having started or changed her oral contraceptive or any other hormonal treatment during the one previous month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mucogyne treatment; 3 planned visits for each eligible patient: Screening/Baseline visit: V0 at Day 0. Patient receive a box of Mucogyne Gel.; Phone call: V1 phone call at Day 10 ± 3; End-of-study visit: V2 at Day 35 ± 3	Device: Mucogyne Gel; At inclusion visit (V0), the Investigator will ask the subject to apply MUCOGYNE® Gel as described in the Instructions For Use, i.e., internally, one application 2 to 3 times a week until symptoms improve during 5 weeks (D35 +/- 3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the efficacy of MUCOGYNE® Gel intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use.	Primary efficacy criterion: Clinical scoring, by the investigator, of the Vaginal Health Index Score (VHIS), including evaluation of elasticity, fluid volume, pH, epithelial integrity, and moisture.	Day 0 to Day 35 +/- 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation	Secondary efficacy criteria - Auto-evaluation, by the subjects, of pain and/or dyspareunia on Visual Analogical Scales (VAS) from 0 to 10	Day 0 to Day 35 +/- 3
Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness	Secondary efficacy criteria - Clinical scoring of vulvo-vaginal dryness by the Investigator on a Visual Analogical Scale from 0 to 10	Day 0 to Day 35 +/- 3
Assessment by investigator of changes in patient's clinical status	Secondary efficacy criteria - Completion of the CGI-I (Clinical Global Impressions-Improvement) by the Investigator.	Day 0 to Day 35 +/- 3
Assessment of changes in patient's clinical status	Secondary efficacy criteria - Completion of the Patients' Global Impression of Change (PGIC) Scale to assess the changes perceived by the patient following the treatment taken.	Day 0 to Day 35 +/- 3
Assessment of the patient's satisfaction	Secondary efficacy criteria - Completion of the intra vaginal treatment satisfaction questionnaire (Likert questionnaire) to assess the level of satisfaction of the treatment on the vaginal symptoms.	Day 0 to Day 35 +/- 3
Assessment of the patient's sexual function	Secondary efficacy criteria - Completion of the self-reported FSFI (Female Sexual Function Index) to investigate sexual function (for women having sexual relations).	Day 0 to Day 35 +/- 3

Collaborators and Investigators

• Sponsor: Biocodex
• Collaborators: Voisin Consulting Life Science (VCLS)
• Investigators: Study Director: Oana BERNARD, MD, Chief Scientific Officer

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MUCG234; 2022-A02088-35 (Other Identifier: ID-RCB)

Drug and device information, study documents

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