Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).

Detailed Description
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This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up. The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening. The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.

Official Title
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Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

Conditions
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Vaginal Disease

Intervention / Treatment
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* Device: Hidrante HA
* Device: Cumlaude Hidrante Interno®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multicenter, randomized, controlled, double-blind study with two parallel group of subjects. The clinical investigation will be performed in 9 clinical sites. The follow-up will be 4 weeks, with 3 face-to-face controls (baseline, 7 days and 30 days) and 2 telephone controls (3 days and 21 days). At all on-site visits (baseline, Day 7, Day 30), the investigator will record the severity of patient-reported symptoms (via VAS of 0 to 100 mm) and perform a gynecological examination to evaluate signs of vaginal atrophy. Potential adverse events and potential device deficiencies will be recorded at each visit. The patients will have a patient notebook where they will record the intensity of the symptoms on the third day and weekly, as well as the possible appearance of adverse events or product deficiencies.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hidratante HA<br>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. | Device: Hidrante HA<br>* Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.<br>* Other names: Experimental;|
| Active Comparator: Cumlaude Hidratante Interno®<br>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. | Device: Cumlaude Hidrante Interno®<br>* Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Health Index | The Vaginal Health Index ranges from a minimum of 5 to a maximum of 25. The change will be assessed by comparing scores from baseline to 30 days (final visit); with comparison intra and inter groups. | At the end of study (Day 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of subjective symptoms (investigator record) | Severity of dryness, itching, burning and dyspareunia reported by the investigator in the data registration form, assessed using a visual analog scale (VAS from 0=none to 10=maximum).The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups. | at 7 days and 30 days. | 
| Subjective symtomps (patient's notebook) | Severity of dryness, itching, burning and dyspareunia reported on patient diary using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to every record (3 days, 7days, 14 days, 21 days and 30 days); with comparison intra and inter groups. | at 3 days, 7days, 14 days, 21 days and 30 days. | 
| Objective signs of vulvovaginal atrophy | Objective signs of vulvovaginal atrophy (dryness, flattening of folds, mucosal pallor, frailty and petechiae) reported by the investigator in the data registration form, assessed using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups. | at 7 days and 30 days. | 
| Vaginal pH | Vaginal pH will be measured by the investigator with a test strip delivered by sponsor. The change will be assessed by comparing pH values from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | 
| Sexual function | Female Sexual Function Index (FSFI) questionnaire will be answered by the patients at the baseline and 30-day visits. The change will be assessed by comparing FSFI scores from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | 
| Global Symptom Score (GSS) | Global Symptom Score (GSS) will be assessed by the sum of severity scores of each symptom: dryness, itching, burning/stinging and dyspareunia (0 = none, 1 = mild, 2 = moderate and 3 = severe). GSS score ranges from 0 to 12. The change will be assessed by comparing GSS scores from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | 
| Adverse events as a measure of Safety and Tolerability | Number of participants with incidence of treatment-related adverse events, serious adverse events and device deficiencies as a Measure of Safety and Tolerability. | At the end of study (Day 30) | 
| Overall Safety Assessment | Overall patient and investigator safety rating, using 4-point Likert-type scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5=very poor); with comparison inter groups. | At the end of study (Day 30) | 
| Patient satisfaction | The patient's degree of satisfaction with the product will be rated using a 5-point Likert-type scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5=very dissatisfied); with comparison inter groups. | At the end of study (Day 30) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Disease, Vaginal Dryness, Vaginal Atrophy