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

NCT04355403 | Completed

• 1 other identifier: QQ53-18-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Vulvovaginal Atrophy

Keywords

Hyaluronic Acid; Post-menopause

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline to 12 weeks of treatment

Secondary Outcomes (11)

• Change of patient's perception of vulvovaginal dryness

  From baseline to 4 weeks of treatment

• Change of patient's perception of vulvovaginal symptoms

  From baseline to 4 and 12 weeks of treatment

• Change of the average score of Vaginal Health Index (VHI)

  From baseline to 4 and 12 weeks of treatment

• Change of vaginal pH

  From baseline to 4 and 12 weeks of treatment

• Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)

  From baseline to 4 and 12 weeks of treatment

Study Arms (2)

Hyalo Gyn gel

EXPERIMENTAL

Vaginal application of Hyalo Gyn gel in prefilled applicators

Device: Hyalo Gyn gel in prefilled applicators

No treatment

NO INTERVENTION

No treatment application

Interventions

Hyalo Gyn gel in prefilled applicators DEVICE

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

Hyalo Gyn gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Selection of post-menopausal women with symptoms of vulvovaginal atrophy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (2)

Gynkomed s.r.o.

Bratislava, 83107, Slovakia

Location

ULMUS, s r.o.

Hlohovec, 920 01, Slovakia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: February 5, 2019
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

SL (2)