Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness (HYALU-LAUDE)
Vaginal Disease
About this trial
This is an interventional treatment trial for Vaginal Disease focused on measuring Vaginal Disease, Vaginal Dryness, Vaginal Atrophy
Eligibility Criteria
Inclusion Criteria: Women over 18 years of age who manifest subjective symptoms of vaginal dryness (dryness, itching, burning/stinging and dyspareunia). In the case of postmenopausal women, they must have a diagnosis confirmed by the gynecologist of the presence of signs of vulvovaginal dryness/atrophy (Vaginal Health Index score <15). Patients who have not used any topical treatment, moisturizer or vaginal lubricant for at least 7 days prior to the start of the study and agree not to use it during the study period. Patients who agree to participate and sign the Informed Consent form. Exclusion Criteria: Pregnant women Malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin). Genital bleeding. Treatment with vaginal or systemic estrogens in the 3 months prior to study inclusion or during the study period. I said above Subjects with illness or other medical condition that, in the investigator's opinion, would compromise participation or could lead to hospitalization during the study. Clinical evidence of acute infection that requires treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e., tuberculosis), with the exception of HPV-carrying women with no lesions. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except intermittent anxiety). Known allergy to the components of the investigational product or its excipients. Drug or alcohol abuse in the 12 months prior to the start of the study. Participation in an interventional clinical study or administration of any investigational agent within the previous 30 days. Patients with low expectation of compliance with the study protocol.
Sites / Locations
- Corofas MenopauseRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Hidratante HA
Cumlaude Hidratante Interno®
The investigational product consists of a new vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code. For each participant, the total duration of treatment will be 4 weeks.
The investigational product is a marketed vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code. For each participant, the total duration of treatment will be 4 weeks.