Clinical trial NCT04355403: Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Keywords: Hyaluronic Acid
Post-menopause
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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), 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.

Primary outcomes:
measure: Change of patient's perception of vulvovaginal dryness
timeFrame: From baseline to 12 weeks of treatment
Secondary outcomes:
measure: Change of patient's perception of vulvovaginal dryness
timeFrame: From baseline to 4 weeks of treatment
measure: Change of patient's perception of vulvovaginal symptoms
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Change of the average score of Vaginal Health Index (VHI)
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Change of vaginal pH
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
timeFrame: From baseline to 4 and 12 weeks of treatment
measure: Amelioration of the vaginal maturation (VM) index
timeFrame: From baseline to 12 weeks of treatment
measure: Patient's global assessment of overall satisfaction
timeFrame: 4 and 12 weeks of treatment
measure: Ease in the method of Hyalo Gyn gel administration
timeFrame: 4 and 12 weeks of treatment
measure: Local tolerability at the application site
timeFrame: 4 and 12 weeks of treatment
measure: Safety of the treatment: Collection of adverse events
timeFrame: 4 and 12 weeks of treatment
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Gynkomed s.r.o.
city: Hlohovec
country: Slovakia
facility: ULMUS, s r.o.
Study officials:
References: