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

Not Applicable

Completed

• Conditions: Vaginal Dryness
• Interventions: Device: Vaginal gel, Medical Device Class 2A

• Registration Number: NCT02994342
• Lead Sponsor: Zambon SpA

Brief Summary

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

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

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-12
• Study Completion: 2015-10
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal gel, Medical Device Class 2A	Vaginal gel, Medical Device Class 2A	Every subject has been treated for 56 consecutive days, twice daily with a vaginal application

Primary Outcome Measures

Name	Time	Method
Change in subjective symptoms of total score related to vaginal discomfort	56 days	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.

Secondary Outcome Measures

Name	Time	Method
change of vaginal health index	56 days	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
change of maturation index	56 days	change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56
change of Female Sexual Function Index	56 days	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
change of cariopicnotic index (CPI),	56 days	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
change in each subjective symptom score related to vaginal discomfort	56 days	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).
local tolerability and incidence of adverse events	56 days	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.
change of Female Sexual Distress Scale-Revised	56 days	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

Trial Locations

Locations (6)

Ospedale San Giovanni di Dio; 🇮🇹 Cagliari, Italy

Policlinico Careggi; 🇮🇹 Firenze, Italy

Clinica Macedonio Melloni; 🇮🇹 Milano, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Policlinico di Modena; 🇮🇹 Modena, Italy