Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Slovakia

Study Type

Interventional

Intervention

Hyalo Gyn gel in prefilled applicators

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Hyaluronic Acid, Post-menopause

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Gynkomed s.r.o.
ULMUS, s r.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hyalo Gyn gel

No treatment

Arm Description

Vaginal application of Hyalo Gyn gel in prefilled applicators

No treatment application

Outcomes

Primary Outcome Measures

Change of patient's perception of vulvovaginal dryness

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 Outcome Measures

Change of patient's perception of vulvovaginal dryness

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).

Change of patient's perception of vulvovaginal symptoms

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)

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

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)

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)

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.

Amelioration of the vaginal maturation (VM) index

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).

Patient's global assessment of overall satisfaction

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

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

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

Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study

Full Information

NCT ID

NCT04355403

First Posted

April 17, 2020

Last Updated

April 17, 2020

Sponsor

Fidia Farmaceutici s.p.a.

1. Study Identification

Unique Protocol Identification Number

NCT04355403

Brief Title

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

February 5, 2019 (Actual)

Primary Completion Date

June 28, 2019 (Actual)

Study Completion Date

June 28, 2019 (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 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.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyalo Gyn gel

Arm Type

Experimental

Arm Description

Vaginal application of Hyalo Gyn gel in prefilled applicators

Arm Title

No treatment

Arm Type

No Intervention

Arm Description

No treatment application

Intervention Type

Device

Intervention Name(s)

Hyalo Gyn gel in prefilled applicators

Intervention Description

One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.

Primary Outcome Measure Information:

Title

Change of patient's perception of vulvovaginal dryness

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).

Time Frame

From baseline to 12 weeks of treatment

Secondary Outcome Measure Information:

Title

Change of patient's perception of vulvovaginal dryness

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).

Time Frame

From baseline to 4 weeks of treatment

Title

Change of patient's perception of vulvovaginal symptoms

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)

Time Frame