Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women

Fidia Farmaceutici s.p.a.2 sites in 1 country40 target enrollmentNovember 29, 2017

ConditionsVulvovaginal Atrophy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vulvovaginal Atrophy
Sponsor: Fidia Farmaceutici s.p.a.
Enrollment: 40
Locations: 2
Primary Endpoint: Change of the average score of Vaginal Health Index (VHI)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 29, 2017

End Date

May 29, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fidia Farmaceutici s.p.a.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: From baseline to 12 weeks of treatment

Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.

Secondary Outcomes

Patient's global assessment of overall satisfaction(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)
Amelioration of the vaginal maturation (VM) index(From baseline to 12 weeks of treatment)
Local tolerability at the application site(4 and 12 weeks of treatment)
Change of the average score of Vaginal Health Index (VHI)(From baseline to 4 weeks of treatment)
Change of vaginal pH(From baseline to 4 and 12 weeks of treatment)
Change of patient's perception of vulvovaginal symptoms(From baseline to 4 and 12 weeks of treatment)
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)(From baseline to 4 and 12 weeks of treatment)
Safety of the treatment: Collection of adverse events(4 and 12 weeks of treatment)