Back to resultsEfficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Primary Purpose
Vulvovaginal Atrophy
Status
Completed
Phase
Not Applicable
Locations
Slovakia
Study Type
Interventional
Intervention
Hydeal-D vaginal pessaries
Sponsored by
About this trial
This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Hyaluronic acid, Post-menopause
Eligibility Criteria
Inclusion Criteria:
- 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)
- Women between 45 and 75 years of age.
- Vaginal pH ≥5
- Vulvovaginal atrophy with VHI < 15
- 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
- Women with active sex lives
- Patients who give written informed consent to participate in the trial
Exclusion Criteria:
- Enrollment in other clinical trials within the previous 1 month.
- Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- Patients in previous treatment with either oral or topical hormonal products within 1 month.
- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
- Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
- Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
- Women with no active sex lives
- Women who do not give informed consent;
- Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient
Sites / Locations
- Gynkomed s.r.o.
- ULMUS, s r.o.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hydeal-D vaginal pessaries
Arm Description
Vaginal application of Hydeal-D vaginal pessaries
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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).
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03557398
Brief Title
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Official Title
Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Hyaluronic acid, Post-menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydeal-D vaginal pessaries
Arm Type
Experimental
Arm Description
Vaginal application of Hydeal-D vaginal pessaries
Intervention Type
Device
Intervention Name(s)
Hydeal-D vaginal pessaries
Other Intervention Name(s)
Hyalogyn vaginal pessaries
Intervention Description
One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
Primary Outcome Measure Information:
Title
Change of the average score of Vaginal Health Index (VHI)
Description
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.
Time Frame
From baseline to 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change of the average score of Vaginal Health Index (VHI)
Description
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.
Time Frame
From baseline to 4 weeks of treatment
Title
Change of vaginal pH
Description
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.
Time Frame
From baseline to 4 and 12 weeks of treatment
Title
Change of patient's perception of vulvovaginal symptoms
Description
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).
Time Frame
From baseline to 4 and 12 weeks of treatment
Title
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Description
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
Title
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Description
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
Title
Amelioration of the vaginal maturation (VM) index
Description
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
Title
Patient's global assessment of overall satisfaction
Description
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
Title
Local tolerability at the application site
Description
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.
Time Frame
4 and 12 weeks of treatment
Title
Safety of the treatment: Collection of adverse events
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Selection of post-menopausal women with symptoms of vulvovaginal atrophy
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Women between 45 and 75 years of age.
Vaginal pH ≥5
Vulvovaginal atrophy with VHI < 15
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
Women with active sex lives
Patients who give written informed consent to participate in the trial
Exclusion Criteria:
Enrollment in other clinical trials within the previous 1 month.
Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
Patients in previous treatment with either oral or topical hormonal products within 1 month.
Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
Women with no active sex lives
Women who do not give informed consent;
Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient
Facility Information:
Facility Name
Gynkomed s.r.o.
City
Bratislava
ZIP/Postal Code
83107
Country
Slovakia
Facility Name
ULMUS, s r.o.
City
Hlohovec
ZIP/Postal Code
920 01
Country
Slovakia
12. IPD Sharing Statement
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Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
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