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

Vaginal Dryness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994342
• Other study ID #: Z7213M02
• Status: Completed
• Phase: N/A
• First received: December 1, 2016
• Last updated: June 27, 2017
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2017
• Source: Zambon SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Dryness

Intervention

Device:
• Vaginal gel, Medical Device Class 2A
Application twice a day of vaginal gel for 56 consecutive days

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni di Dio	Cagliari
Italy	Policlinico Careggi	Firenze
Italy	Clinica Macedonio Melloni	Milano
Italy	Policlinico di Modena	Modena
Italy	Policlinico Federico II	Napoli
Italy	Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Zambon SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	change of maturation index	change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56	56 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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