Phase
Condition
Vaginitis
Vaginal Atrophy
Treatment
Mucogyne Ovule
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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, oritchiness) : women who suffer pain during sexual intercourse, women taking the minipill, mothers during breastfeeding, menopausal women and women taking anti-acnetreatment.
Having a Vaginal Health Index Score (VHIS) <15 associated to pain and/or dyspareuniafeeling.
If the patient has reproductive potential, she must be willing to use effectivemethod of contraception (oral contraceptive, intrauterine device, subcutaneouscontraceptive implant, vaginal ring, and condom).
Patient agrees to not use any local oestrogens, or other vaginal product during thestudy
Patient agrees to not modify their intimate hygiene and lubricant products
Patient able to understand and sign the informed consent form before beginning anystudy procedure
Patient able to comply with study requirements, as defined in the protocol.
Patient affiliated to a health social security system.
Exclusion
Exclusion Criteria:
Women with the following conditions:
General criteria:
Pregnant women (patient of childbearing potential must not be pregnant and mustagree to avoid pregnancy during the study by using an effective birth control methodfrom 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 thefour previous weeks and during the study period, being in an exclusion period for aprevious study
Patient deprived of freedom by administrative or legal decision or underguardianship
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 vaginaldryness/atrophy
Criteria related to previous or ongoing treatments:
Patient with a condition or receiving a medication which, in the investigator'sjudgment, put the patient at undue risk
Patient suffering from systemic diseases and/or using concurrent therapy that mayinterfere with the evaluation of the study results
Patient undergoing a topical treatment on the test area or a systemic treatment suchas:
corticosteroids during the 2 previous weeks and during the study
retinoids and/or immunosuppressors during the 1.5 previous months and duringthe study
Patient having started or changed her oral contraceptive or any other hormonaltreatment during the three previous months
Study Design
Connect with a study center
JEAN Christian's medical office
Nogent-sur-Marne, 94130
FranceSite Not Available
Dr Ramez GHADRI's medical office
Orléans, 45100
FranceSite Not Available
Dr Raïssa APERANO-MAS's medical office
Rennes, 35000
FranceSite Not Available
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