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

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ClinicalTrials.gov Identifier: NCT02994342
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vaginal Dryness Device: Vaginal gel, Medical Device Class 2A Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : October 2015

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 Name: Monurelle Biogel

No Intervention: Lifestyle counseling
Every subject has been observed for 56 consecutive days



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994342


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT02994342     History of Changes
Other Study ID Numbers: Z7213M02
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD should be requested to sposnor contacts

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zambon SpA:
vaginal dryness
vaginal gel
colostrum
vaginal atrophy