Evaluation of the Efficacy and Safety of Mucogye® Gel as... | NCT05913479

NCT05913479

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2022-A02088-35	Other Identifier	ID-RCB

Status Module

Name	Class
Voisin Consulting Life Science (VCLS)	UNKNOWN

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mucogyne treatment	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mucogyne Gel	Device	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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Dr Paul Lefevre's medical office		Caen		14000	France
Dr Thierry KELLER's medical office