Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

Fidia Pharma

Status

Completed

Conditions

Vulvovaginal Atrophy

Treatments

Device: Hydeal-D vaginal pessaries

Study type

Interventional

Funder types

Industry

Identifiers

NCT03557398

QQ53-17-01

Details and patient eligibility

About

This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.

Enrollment

40 patients

Sex

Female

Ages

45 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, or had been surgically postmenopausal for more than 6 months)
Women between 45 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 lives
Patients who give written informed consent to participate in the trial

Exclusion criteria

Enrollment in other clinical trials within the previous 1 month.
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); or history of vulgovaginal contact allergy.
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.
Women with no active sex lives
Women who do not give informed consent;
Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient