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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Dryness
• Intervention / Treatment: Device: Vaginal gel, Medical Device Class 2A

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy
    • Ospedale San Giovanni di Dio
  • Firenze, Italy
    • Policlinico Careggi
  • Milano, Italy
    • Clinica Macedonio Melloni
  • Modena, Italy
    • Policlinico di Modena
  • Napoli, Italy
    • Policlinico Federico II
  • Pavia, Italy
    • Policlinico San Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zambon SpA
• Investigators: Study Director: Rossella Nappi, Md PhD, Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy

Publications and helpful links

General Publications

• Nappi RE, Cagnacci A, Becorpi AM, Nappi C, Paoletti AM, Busacca M, Martella S, Bellafronte M, Tredici Z, Di Carlo C, Corda V, Vignali M, Bagolan M, Sardina M. Monurelle Biogel(R) vaginal gel in the treatment of vaginal dryness in postmenopausal women. Climacteric. 2017 Oct;20(5):467-475. doi: 10.1080/13697137.2017.1335703. Epub 2017 Jun 28.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: colostrum; vaginal dryness; vaginal atrophy; vaginal gel
• Other Study ID Numbers: Z7213M02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD should be requested to sposnor contacts

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No