Vulvovaginal Atrophy
Conditions
Keywords
Hyaluronic Acid, Post-menopause
Brief summary
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.
Interventions
DEVICEHyalo Gyn gel in prefilled applicators
One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.
Sponsors
Fidia Farmaceutici s.p.a.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen). * Women between 18 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 life. * Patients who give written informed consent to participate in the trial.
Exclusion criteria
* Treatment with another investigational product within the previous 3 months. * Previous participation in any clinical study with Hydeal-D based investigational products. * 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); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen. * 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. * Any condition in the investigator's opinion not suitable for the inclusion of the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of patient's perception of vulvovaginal dryness | From baseline to 12 weeks of treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of patient's perception of vulvovaginal symptoms | From baseline to 4 and 12 weeks of treatment | 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) |
| Change of the average score of Vaginal Health Index (VHI) | From baseline to 4 and 12 weeks of treatment | 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. |
| Change of vaginal pH | From baseline to 4 and 12 weeks of treatment | 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. |
| Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI) | From baseline to 4 and 12 weeks of treatment | 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. |
| Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R) | From baseline to 4 and 12 weeks of treatment | 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. |
| Change of patient's perception of vulvovaginal dryness | From baseline to 4 weeks of treatment | 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). |
| Patient's global assessment of overall satisfaction | 4 and 12 weeks of treatment | 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. |
| Ease in the method of Hyalo Gyn gel administration | 4 and 12 weeks of treatment | Ease in the method of Hyalo Gyn gel administration will be reported by the patients as excellent, good, acceptable, bad or unacceptable |
| Local tolerability at the application site | 4 and 12 weeks of treatment | 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) |
| 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 |
| Amelioration of the vaginal maturation (VM) index | From baseline to 12 weeks of treatment | 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). |
Countries
Slovakia
Outcome results
None listed