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

Vaginal Dryness Clinical Trial

— HYDRAGYNE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913479
• Other study ID #: MUCG234
• Secondary ID: 2022-A02088-35
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Biocodex
• Contact: Roxane NOEL
• Phone: +33 3 44 86 75 79
• Email: r.noel[@]biocodex.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Dryness

Intervention

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)

Locations

Country	Name	City	State
France	Dr Paul Lefevre's medical office	Caen
France	Dr Thierry KELLER's medical office	Colmar
France	Dr Christiane ARMAND's medical office	Écully
France	Sihame MOKHBAT's office	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Biocodex	Voisin Consulting Life Science (VCLS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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