Clinical trial NCT06282614: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer
Official title: MOVHYDA (MUCO245) - Performance and Safety of MUCOGYNE® Ovule as a Moisturizer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vaginal Dryness
Lead sponsor: Biocodex
Sponsor class: INDUSTRY
Collaborators: name: Voisin Consulting Life Science (VCLS)
First posted: 2024-02-28
Enrollment: 33
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 is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness.


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) : women who suffer pain during sexual intercourse, women taking the mini pill, mothers during breastfeeding, menopausal women and women taking anti-acne treatment.
* Having a Vaginal Health Index Score (VHIS) \<15 associated to pain and/or dyspareunia feeling.
* If the patient has reproductive potential, she must be willing to use effective method of contraception (oral contraceptive, intrauterine device, subcutaneous contraceptive implant, vaginal ring, and condom).
* Patient agrees to not use any local oestrogens, or other vaginal product during the study
* Patient agrees to not modify their intimate hygiene and lubricant products
* Patient able to understand and sign the informed consent form before beginning any study procedure
* Patient able to comply with study requirements, as defined in the protocol.
* Patient affiliated to a health social security system.

Exclusion Criteria:

Women with the following conditions:

General criteria:

* Pregnant women (patient 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 (V1) and throughout the duration of the study)
* Patient 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
* Patient deprived of freedom by administrative or legal decision or under guardianship
* Patient in a social or sanitary establishment
* Patient suspected to be non-compliant according to the investigator's judgment
* Patient in an emergency situation

Criteria related to patient's status:

* Patient with known hypersensitivity to one of MUCOGYNE® Ovule components
* Patient with a known vaginal pathology (clinical diagnosis only) other than vaginal dryness/atrophy

Criteria related to previous or ongoing treatments:

* Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk
* Patient suffering from systemic diseases and/or using concurrent therapy that may interfere with the evaluation of the study results
* Patient undergoing a topical treatment on the test area or a systemic treatment such as:

  * corticosteroids during the 2 previous weeks and during the study
  * retinoids and/or immunosuppressors during the 1.5 previous months and during the study
  * Patient having started or changed her oral contraceptive or any other hormonal treatment during the three previous months

Primary outcomes:
measure: Assessment of the efficacy of MUCOGYNE® Ovule 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® Ovule in reducing vulva irritation
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the patient's sexual function
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the patient's satisfaction
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 by investigator of changes in patient's clinical status
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the safety of MUCOGYNE® Ovule
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the device deficiencies of MUCOGYNE® Ovule
timeFrame: Day 0 to Day 35 ± 3
measure: Assessment of the usability of MUCOGYNE® Ovule
timeFrame: Day 0 to Day 35 ± 3
Other outcomes:
Locations:
city: Nogent-sur-Marne
country: France
facility: JEAN Christian's medical office
city: Orléans
country: France
facility: Dr Ramez GHADRI's medical office
city: Rennes
country: France
facility: Dr Raïssa APERANO-MAS's medical office
Study officials:
affiliation: Chief Scientific Officer
name: Oana BERNARD, MD
role: STUDY_DIRECTOR
References: