Clinical trial NCT05913479: Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
Official title: HYDRAGYNE (MUCG234) - Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Dryness
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
Collaborators: name: Voisin Consulting Life Science (VCLS)
First posted: 2023-06-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter (France), open label without comparator study
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: 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.
timeFrame: Day 0 to Day 35 +/- 3
Secondary outcomes:
measure: Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation
timeFrame: Day 0 to Day 35 +/- 3
measure: Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness
timeFrame: Day 0 to Day 35 +/- 3
measure: Assessment by investigator of changes in patient's clinical status
timeFrame: Day 0 to Day 35 +/- 3
measure: Assessment of changes in patient's clinical status
timeFrame: Day 0 to Day 35 +/- 3
measure: Assessment of the patient's satisfaction
timeFrame: Day 0 to Day 35 +/- 3
measure: Assessment of the patient's sexual function
timeFrame: Day 0 to Day 35 +/- 3
Other outcomes:
Locations:
city: Caen
country: France
facility: Dr Paul Lefevre's medical office
city: Colmar
country: France
facility: Dr Thierry KELLER's medical office
city: Paris
country: France
facility: Sihame MOKHBAT's office
city: Écully
country: France
facility: Dr Christiane ARMAND's medical office
Study officials:
affiliation: Chief Scientific officer
name: Oana BERNARD, MD
role: STUDY_DIRECTOR
References: