Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

Study Overview
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Brief Summary
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Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.

Detailed Description
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Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days. This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs. This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks

Official Title
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Efficacy, Tolerability and Safety of a New Medical Device, Zp-025 Vaginal Gel, in the Treatment of Vaginal Dryness in Post-menopausal Women With Vaginal Atrophy

Conditions
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Vaginal Dryness

Intervention / Treatment
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* Device: Vaginal gel, Medical Device Class 2A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: caucasian women <70 years, in physiological postmenopausal status for at least 2 years; women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness); signed informed consent; willing and able to comply with study procedures Exclusion Criteria: childbearing potential women; ascertained or presumptive hypersensitivity to the formulation ingredients; therapy with systemic or vaginal oestrogens within 6 months from the inclusion; current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion); previous episodes of vaginal bleeding or spotting in the last 6 months; vaginal prolapse and any other disease that could interfere with the study conduction and participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal gel, Medical Device Class 2A<br>Every subject has been treated for 56 consecutive days, twice daily with a vaginal application | Device: Vaginal gel, Medical Device Class 2A<br>* Application twice a day of vaginal gel for 56 consecutive days<br>* Other names: Monurelle Biogel;|
| No Intervention: Lifestyle counseling<br>Every subject has been observed for 56 consecutive days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective symptoms of total score related to vaginal discomfort | Change in subjective symptoms of total score related to vaginal discomfort (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). Each item is summed up to get to a total symptoms score. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of vaginal health index | change of vaginal health index calculated on the basis of vaginal moistness, vaginal fluid volume, vaginal elasticity, vaginal mucosa, and vaginal pH on a scale ranging from 1 (poorest) to 5 (best) from baseline (day 0), to day 56 recorded by investigator | 56 days | 
| change of maturation index | change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56 | 56 days | 
| change of Female Sexual Function Index | change of Female Sexual Function Index (FSFI) from baseline to day 56 in women with at least one sexual intercourse in the treatment period recorded by subject | 56 days | 
| change in each subjective symptom score related to vaginal discomfort | change in each symptom score from baseline to end of study recorded on daily diary by subject(vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, and dyspareunia and vaginal bleeding associated with sexual activity) has been recorded on daily diary by subject from baseline to day 56, evaluated using a subjective evaluation scale (VRS at four items: 0= absent, 1= mild, 2=moderate, 3=severe). | 56 days | 
| local tolerability and incidence of adverse events | local tolerability registered daily by subject in the subject's diary during the application; period and by the investigator from baseline to day 56; AEs registered over all study period (first patient in - last patient out) - In particular the following assessments will be done: vital signs during all visits. transvaginal ecography to exclude any possible endometrial disease or endometrial thickness variation at the screening visit and at the end of the study, clinical evaluation by the investigator at all visits. | 56 days | 
| change of Female Sexual Distress Scale-Revised | change of Female Sexual Distress Scale-Revised (FSDS-R revised 2005) from baseline (Day 0) to day 28 and to the end of the study in women with at least one sexual intercourse in the treatment period recorded by subject | 56 days | 
| change of cariopicnotic index (CPI), | change of cariopicnotic index (CPI), as a correlation of superficial cells with picnotic nuclear and general amount of cells ratio, expressed in percentage from baseline (day 0), to day 56 | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal dryness, vaginal gel, colostrum, vaginal atrophy