Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hydeal-D vaginal pessaries Vaginal application of Hydeal-D vaginal pessaries |
Device: Hydeal-D vaginal pessaries
One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change of the average score of Vaginal Health Index (VHI) [From baseline to 12 weeks of treatment]
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.
Secondary Outcome Measures
- Change of the average score of Vaginal Health Index (VHI) [From baseline to 4 weeks of treatment]
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.
- Change of vaginal pH [From baseline to 4 and 12 weeks of treatment]
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.
- Change of patient's perception of vulvovaginal symptoms [From baseline to 4 and 12 weeks of treatment]
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).
- Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI) [From baseline to 4 and 12 weeks of treatment]
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.
- Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R) [From baseline to 4 and 12 weeks of treatment]
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.
- Amelioration of the vaginal maturation (VM) index [From baseline to 12 weeks of treatment]
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).
- Patient's global assessment of overall satisfaction [4 and 12 weeks of treatment]
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.
- Local tolerability at the application site [4 and 12 weeks of treatment]
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.
- Safety of the treatment: Collection of adverse events [4 and 12 weeks of treatment]
Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study
Eligibility Criteria
Criteria
Inclusion Criteria:
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Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L, or had been surgically postmenopausal for more than 6 months)
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Women between 45 and 75 years of age.
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Vaginal pH ≥5
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Vulvovaginal atrophy with VHI < 15
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At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
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Women with active sex lives
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Patients who give written informed consent to participate in the trial
Exclusion Criteria:
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Enrollment in other clinical trials within the previous 1 month.
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Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
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Patients in previous treatment with either oral or topical hormonal products within 1 month.
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Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
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Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
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Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
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Women with no active sex lives
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Women who do not give informed consent;
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Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gynkomed s.r.o. | Bratislava | Slovakia | 83107 | |
| 2 | ULMUS, s r.o. | Hlohovec | Slovakia | 920 01 |
Sponsors and Collaborators
- Fidia Farmaceutici s.p.a.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QQ53-17-01