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®).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
Corofas Menopause
Tomelloso, Ciudad Real, Spain
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.
Time frame: At the end of study (Day 30)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of study (Day 30)