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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 28, 2019

Interventions

  • Device: Hyalo Gyn gel in prefilled applicators
    • One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.

Arms, Groups and Cohorts

  • Experimental: Hyalo Gyn gel
    • Vaginal application of Hyalo Gyn gel in prefilled applicators
  • No Intervention: No treatment
    • No treatment application

Clinical Trial Outcome Measures

Primary Measures

  • Change of patient’s perception of vulvovaginal dryness
    • Time Frame: 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 Measures

  • Change of patient’s perception of vulvovaginal dryness
    • Time Frame: 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).
  • Change of patient’s perception of vulvovaginal symptoms
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 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.
  • Amelioration of the vaginal maturation (VM) index
    • Time Frame: 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).
  • Patient’s global assessment of overall satisfaction
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Selection of post-menopausal women with symptoms of vulvovaginal atrophy

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fidia Farmaceutici s.p.a.
  • Provider of Information About this Clinical Study
    • Sponsor

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