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

NCT ID: NCT03557398

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2018-05-29

Brief Summary

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.

Conditions

Vulvovaginal Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydeal-D vaginal pessaries

Vaginal application of Hydeal-D vaginal pessaries

Group Type: EXPERIMENTAL

Hydeal-D vaginal pessaries

Intervention Type: DEVICE

One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.

Interventions

Hydeal-D vaginal pessaries

One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.

Intervention Type: DEVICE

Other Intervention Names

Hyalogyn vaginal pessaries

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, 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

• Minimum Eligible Age: 45 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

QQ53-17-01

Identifier Type: -

Identifier Source: org_study_id