Vaginal DrynessNCT02994342
Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness
A study testing Vaginal gel, Medical Device Class 2A in people with Vaginal Dryness, run by Zambon SpA at 6 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Vaginal gel, Medical Device Class 2A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 6 sitesItaly
- Study dates
- Oct 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedale San Giovanni di Dio
Cagliari
Policlinico Careggi
Florence
Clinica Macedonio Melloni
Milan
Policlinico di Modena
Modena
Policlinico Federico II
Naples
Policlinico San Matteo
Pavia
About this study
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
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.
Read the 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
- Conditions
- Vaginal Dryness
- Being tested
- Vaginal gel, Medical Device Class 2A
- Keywords
- vaginal dryness, vaginal gel, colostrum, vaginal atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal gel, Medical Device Class 2ADevice
Also called Monurelle Biogel
Application twice a day of vaginal gel for 56 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Vaginal gel, Medical Device Class 2A | Active comparator | Every subject has been treated for 56 consecutive days, twice daily with a vaginal application Receives: Device: Vaginal gel, Medical Device Class 2A |
| Lifestyle counseling | No intervention | Every subject has been observed for 56 consecutive days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Secondary outcomes (7)
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
Measured: 56 days
change of maturation index
change of maturation index: parabasal, intermediate and superficial cells from baseline (day 0) to day 56
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DrynessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zambon SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rossella Nappi, Md PhD, Study director, Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994342
- Sponsor's protocol ID
- Z7213M02
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2016
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD should be requested to sposnor contacts
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.
PubMed 28657769
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02994342
- Acronym / sponsor ID
- Z7213M02
- Conditions
- Vaginal Dryness
- Keywords
- vaginal dryness, vaginal gel, colostrum, vaginal atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Zambon SpAIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal gel, Medical Device Class 2A | Active comparator | Device: Vaginal gel, Medical Device Class 2AEvery subject has been treated for 56 consecutive days, twice daily with a vaginal application |
| Lifestyle counseling | No intervention | –Every subject has been observed for 56 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal gel, Medical Device Class 2AAlso: Monurelle BiogelApplication twice a day of vaginal gel for 56 consecutive days | Device | Vaginal gel, Medical Device Class 2A |
Primary outcome
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.
7 secondary outcomes
change of vaginal health index
Time frame: 56 days
change of maturation index
Time frame: 56 days
change of Female Sexual Function Index
Time frame: 56 days
change in each subjective symptom score related to vaginal discomfort
Time frame: 56 days
local tolerability and incidence of adverse events
Time frame: 56 days
change of Female Sexual Distress Scale-Revised
Time frame: 56 days
change of cariopicnotic index (CPI),
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Derived from this study: PubMed 28657769Nappi 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.
- Individual participant dataSharing planned: Yes. IPD should be requested to sposnor contacts
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Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial
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F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rossella Nappi, Md PhD study director
Obstetrics and Gynaecology Clinic IRCCS Fondazione San Matteo University of Pavia, Italy
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal gel, Medical Device Class 2A in people with Vaginal Dryness, run by Zambon SpA at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective symptoms of total score related to vaginal discomfort (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.