Skip to main content
OpenTrials
Completed

NCT Number: NCT02994342

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginal Dryness

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale San Giovanni di Dio, Cagliari, Italy

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal gel, Medical Device Class 2A

Device

Application twice a day of vaginal gel for 56 consecutive days

Other names: Monurelle Biogel

Primary outcomes

  1. Change in subjective symptoms of total score related to vaginal discomfort

    Time frame: 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 outcomes

  1. change of vaginal health index

    Time frame: 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

  2. change of maturation index

    Time frame: 56 days

    change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56

  3. change of Female Sexual Function Index

    Time frame: 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

  4. change in each subjective symptom score related to vaginal discomfort

    Time frame: 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).

  5. local tolerability and incidence of adverse events

    Time frame: 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.

  6. change of Female Sexual Distress Scale-Revised

    Time frame: 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

  7. change of cariopicnotic index (CPI),

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zambon SpA

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Dec 15, 2016
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.