This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.
Gynkomed s.r.o.
Bratislava, Slovakia
ULMUS, s r.o.
Hlohovec, Slovakia
Change of patient's perception of vulvovaginal dryness
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
Time frame: From baseline to 12 weeks of treatment
Change of patient's perception of vulvovaginal dryness
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
Time frame: From baseline to 4 weeks of treatment
Change of patient's perception of vulvovaginal symptoms
Change of patient's perception of symptoms associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Each symptom (dryness, irritation/itching, soreness, dysuria, dyspareunia) will be reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe)
Time frame: From baseline to 4 and 12 weeks of treatment
Change of the average score of Vaginal Health Index (VHI)
Change of VHI in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. VHI will be calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
Time frame: From baseline to 4 and 12 weeks of treatment
Change of vaginal pH
Change of vaginal pH in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The pH values are grouped on a four-point scale and scored respectively: pH lower than 5 = 0; pH between 5 and 5.49 = 1; pH between 5.5 and 6.49 = 2; pH higher than 6.49 =3.
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Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Improvement of sexual function in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Female Sexual Function Index (FSFI) questionnaire consists of six domains - desire (two items), arousal (four items), lubrication (four items), orgasm (three items), satisfaction (three items), and pain (three items) - answered on a five-point Likert scale (0, no sexual activity; 1, never/very low; 5, always/very high). A score is calculated for each of the six domains, and the total score is obtained by summing all of the items. Total score ranges from 2 to 36. A lower score corresponds to a greater sexual dysfunction.
Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Improvement of sexual function in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Female Sexual Distress Scale-Revised (FSDS-R) questionnaire consists of 13 items scored on a five-point scale (0, never; 1, rarely; 2, occasionally; 2, frequently; 4, always). The total score is obtained by summing all of the items. Total score ranges from 0 to 52. A higher score corresponds to a greater sexual dysfunction.
Time frame: From baseline to 4 and 12 weeks of treatment
Amelioration of the vaginal maturation (VM) index
Amelioration of VMI in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Vaginal maturation (VM) index is calculated quantifying the percentages of parabasal, intermediate, and superficial cells. The following formula is used: VMI = \[1(% superficial cells)\] + \[0.6(% intermediate cells)\] + \[0.2(% parabasal cells)\]. The index ranges from 0% to 100%.The higher the maturation index, the higher the number of mature cells (0%-49%, low stimulation of the vaginal epithelium; 50%-64%, moderate stimulation of the vaginal epithelium; 65%-100%, high stimulation of the vaginal epithelium).
Time frame: From baseline to 12 weeks of treatment
Patient's global assessment of overall satisfaction
Patient's global assessment of overall satisfaction in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group.Patient's global assessment (PTGA) is evaluated as the patient's overall satisfaction of the treatment scored on a four grade scale, ranging from 0 to 3 (0= dissatisfied or very dissatisfied, 1= moderately satisfied or satisfied, 2= very satisfied and 3= greatly satisfied). A higher score corresponds to a greater satisfaction.
Time frame: 4 and 12 weeks of treatment
Ease in the method of Hyalo Gyn gel administration
Ease in the method of Hyalo Gyn gel administration will be reported by the patients as excellent, good, acceptable, bad or unacceptable
Time frame: 4 and 12 weeks of treatment
Local tolerability at the application site
Local tolerability of Hyalo Gyn gel at the application site will be evaluated by both the clinician and the patient through a 5-point scale: 5 = excellent (no reaction), 4 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 2 = poor (reaction needing interruption of treatment), 1 = bad (serious reaction)
Time frame: 4 and 12 weeks of treatment
Safety of the treatment: Collection of adverse events
Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study
Time frame: 4 and 12 weeks of treatment