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This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydeal-D vaginal pessaries | Experimental | Vaginal application of Hydeal-D vaginal pessaries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydeal-D vaginal pessaries | Device | One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of the average score of Vaginal Health Index (VHI) | Change of Vaginal Health Index (VHI) 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. | From baseline to 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the average score of Vaginal Health Index (VHI) | Change of Vaginal Health Index (VHI) 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. |
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Inclusion Criteria:
Exclusion Criteria:
Selection of post-menopausal women with symptoms of vulvovaginal atrophy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynkomed s.r.o. | Bratislava | 83107 | Slovakia | |||
| ULMUS, s r.o. |
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| From baseline to 4 weeks of treatment |
| Change of vaginal pH | 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. | From baseline to 4 and 12 weeks of treatment |
| Change of patient's perception of vulvovaginal symptoms | Symptoms associated with vulvovaginal atrophy (dryness, irritation/itching, soreness, dysuria, dyspareunia) are reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe). | From baseline to 4 and 12 weeks of treatment |
| Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI) | 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. | From baseline to 4 and 12 weeks of treatment |
| Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R) | 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. | From baseline to 4 and 12 weeks of treatment |
| Amelioration of the vaginal maturation (VM) index | 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). | From baseline to 12 weeks of treatment |
| Patient's global assessment of overall satisfaction | 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. | 4 and 12 weeks of treatment |
| Local tolerability at the application site | Local tolerability of the product at the application site is evaluated by both the clinician and the patient independently, through a 5-point scale, ranging from 0 to 5 (1 = excellent (no reaction), 2 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 4 = poor (reaction needing interruption of treatment), 5 = bad (serious reaction)). A higher score corresponds to a better tolerability. | 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 | 4 and 12 weeks of treatment |
| Hlohovec |
| 920 01 |
| Slovakia |