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

NCT ID: NCT04355403

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2019-06-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyalo Gyn gel

Vaginal application of Hyalo Gyn gel in prefilled applicators

Group Type: EXPERIMENTAL

Hyalo Gyn gel in prefilled applicators

Intervention Type: DEVICE

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

No treatment

No treatment application

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hyalo Gyn gel in prefilled applicators

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gynkomed s.r.o.

Bratislava, , Slovakia

ULMUS, s r.o.

Hlohovec, , Slovakia

Countries

Slovakia

Other Identifiers

QQ53-18-01

Identifier Type: -

Identifier Source: org_study_id