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

Not Applicable

Completed

• Conditions: Vaginal Dryness
• Interventions: Device: Mucogyne Gel

• Registration Number: NCT05913479
• Lead Sponsor: Biocodex

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-10-10
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mucogyne treatment	Mucogyne Gel	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

Primary Outcome Measures

Name	Time	Method
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.	Day 0 to Day 35 +/- 3	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of the patient's sexual function	Day 0 to Day 35 +/- 3	Secondary efficacy criteria; - Completion of the self-reported FSFI (Female Sexual Function Index) to investigate sexual function (for women having sexual relations).
Assessment of the local performance of MUCOGYNE® Gel in reducing vulvo-vaginal dryness	Day 0 to Day 35 +/- 3	Secondary efficacy criteria; - Clinical scoring of vulvo-vaginal dryness by the Investigator on a Visual Analogical Scale from 0 to 10
Assessment of the patient's satisfaction	Day 0 to Day 35 +/- 3	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.
Assessment by investigator of changes in patient's clinical status	Day 0 to Day 35 +/- 3	Secondary efficacy criteria; - Completion of the CGI-I (Clinical Global Impressions-Improvement) by the Investigator.
Assessment of changes in patient's clinical status	Day 0 to Day 35 +/- 3	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.
Assessment of the local performance of MUCOGYNE® Gel in reducing vulva irritation	Day 0 to Day 35 +/- 3	Secondary efficacy criteria; - Auto-evaluation, by the subjects, of pain and/or dyspareunia on Visual Analogical Scales (VAS) from 0 to 10

Trial Locations

Locations (4)

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, France