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

Fidia Pharma

Status

Completed

Conditions

Vulvovaginal Atrophy

Treatments

Device: Hyalo Gyn gel in prefilled applicators

Study type

Interventional

Funder types

Industry

Identifiers

NCT04355403

QQ53-18-01

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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.