Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04355403
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of patient's perception of vulvovaginal dryness", 'timeFrame': 'From baseline to 12 weeks of treatment', 'description': "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)."}], 'secondaryOutcomes': [{'measure': "Change of patient's perception of vulvovaginal dryness", 'timeFrame': 'From baseline to 4 weeks of treatment', 'description': "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)."}, {'measure': "Change of patient's perception of vulvovaginal symptoms", 'timeFrame': 'From baseline to 4 and 12 weeks of treatment', 'description': "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)"}, {'measure': 'Change of the average score of Vaginal Health Index (VHI)', 'timeFrame': 'From baseline to 4 and 12 weeks of treatment', 'description': '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.'}, {'measure': 'Change of vaginal pH', 'timeFrame': 'From baseline to 4 and 12 weeks of treatment', 'description': '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.'}, {'measure': 'Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)', 'timeFrame': 'From baseline to 4 and 12 weeks of treatment', 'description': '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.'}, {'measure': 'Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)', 'timeFrame': 'From baseline to 4 and 12 weeks of treatment', 'description': '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.'}, {'measure': 'Amelioration of the vaginal maturation (VM) index', 'timeFrame': 'From baseline to 12 weeks of treatment', 'description': '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).'}, {'measure': "Patient's global assessment of overall satisfaction", 'timeFrame': '4 and 12 weeks of treatment', 'description': "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."}, {'measure': 'Ease in the method of Hyalo Gyn gel administration', 'timeFrame': '4 and 12 weeks of treatment', 'description': 'Ease in the method of Hyalo Gyn gel administration will be reported by the patients as excellent, good, acceptable, bad or unacceptable'}, {'measure': 'Local tolerability at the application site', 'timeFrame': '4 and 12 weeks of treatment', 'description': '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)'}, {'measure': 'Safety of the treatment: Collection of adverse events', 'timeFrame': '4 and 12 weeks of treatment', 'description': 'Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic Acid', 'Post-menopause'], 'conditions': ['Vulvovaginal Atrophy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Selection of post-menopausal women with symptoms of vulvovaginal atrophy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels \\>40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).\n* Women between 18 and 75 years of age.\n* Vaginal pH ≥5.\n* Vulvovaginal atrophy with VHI \\< 15.\n* 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.\n* Women with active sex life.\n* Patients who give written informed consent to participate in the trial.\n\nExclusion Criteria:\n\n* Treatment with another investigational product within the previous 3 months.\n* Previous participation in any clinical study with Hydeal-D based investigational products.\n* Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week\n* Patients in previous treatment with either oral or topical hormonal products within 1 month.\n* Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.\n* Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.\n* Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.\n* Any condition in the investigator's opinion not suitable for the inclusion of the patient."}, 'identificationModule': {'nctId': 'NCT04355403', 'briefTitle': 'Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fidia Farmaceutici s.p.a.'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Open-label Clinical Investigation to Assess the Performance and Safety of Hyalo Gyn Gel Prefilled Applicators on the Treatment of Vaginal Atrophy in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'QQ53-18-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyalo Gyn gel', 'description': 'Vaginal application of Hyalo Gyn gel in prefilled applicators', 'interventionNames': ['Device: Hyalo Gyn gel in prefilled applicators']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'No treatment application'}], 'interventions': [{'name': 'Hyalo Gyn gel in prefilled applicators', 'type': 'DEVICE', 'description': 'One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.', 'armGroupLabels': ['Hyalo Gyn gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83107', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Gynkomed s.r.o.', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '920 01', 'city': 'Hlohovec', 'country': 'Slovakia', 'facility': 'ULMUS, s r.o.', 'geoPoint': {'lat': 48.43174, 'lon': 17.8031}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fidia Farmaceutici s.p.a.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}