- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557398
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
June 4, 2018 updated by: Fidia Farmaceutici s.p.a.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bratislava, Slovakia, 83107
- Gynkomed s.r.o.
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Hlohovec, Slovakia, 920 01
- ULMUS, s r.o.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hydeal-D vaginal pessaries
Vaginal application of Hydeal-D vaginal pessaries
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One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the average score of Vaginal Health Index (VHI)
Time Frame: From baseline to 12 weeks of treatment
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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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From baseline to 12 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the treatment: Collection of adverse events
Time Frame: 4 and 12 weeks of treatment
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Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study
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4 and 12 weeks of treatment
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Change of the average score of Vaginal Health Index (VHI)
Time Frame: From baseline to 4 weeks of treatment
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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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From baseline to 4 weeks of treatment
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Change of vaginal pH
Time Frame: From baseline to 4 and 12 weeks of treatment
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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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From baseline to 4 and 12 weeks of treatment
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Change of patient's perception of vulvovaginal symptoms
Time Frame: From baseline to 4 and 12 weeks of treatment
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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).
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From baseline to 4 and 12 weeks of treatment
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Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Time Frame: From baseline to 4 and 12 weeks of treatment
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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.
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From baseline to 4 and 12 weeks of treatment
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Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Time Frame: From baseline to 4 and 12 weeks of treatment
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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.
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From baseline to 4 and 12 weeks of treatment
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Amelioration of the vaginal maturation (VM) index
Time Frame: 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).
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From baseline to 12 weeks of treatment
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Patient's global assessment of overall satisfaction
Time Frame: 4 and 12 weeks of treatment
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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.
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4 and 12 weeks of treatment
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Local tolerability at the application site
Time Frame: 4 and 12 weeks of treatment
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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.
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4 and 12 weeks of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 29, 2017
Primary Completion (ACTUAL)
May 29, 2018
Study Completion (ACTUAL)
May 29, 2018
Study Registration Dates
First Submitted
May 18, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (ACTUAL)
June 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QQ53-17-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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