Back to resultsOpen Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Primary Purpose
Vaginal Disease
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Ainara
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Disease
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal women (total cessation of menses for ≥ 1 year) according to the STRAW criteria, aged ≥ 50 to ≤ 70 years;
Diagnosis of vaginal dryness by:
- Subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study
- VHI < 15.
- Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2;
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion Criteria:
- Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- Genital bleeding.
- Estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study).
- Systemic estrogen therapy (it was permitted only if terminated at least 6 months before study).
- Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study or be likely to lead to hospitalization during the course of the study.
- Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
- Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
- Known allergy to tested IMDs or its excipients.
- Drug or alcohol abuse in the 12 months prior to Day 0.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
- Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
Sites / Locations
- Fizio Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ainara
Arm Description
Ainara is a class II medical device, already marketed in several EU countries. Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).
Outcomes
Primary Outcome Measures
Vaginal Health Index (VHI)
Vaginal Health Index: the changing from baseline to day 30 (final visit) for VHI mean value; The minim score is 5 and the maxim is is 25. For a patient to be included in study, the score must be lower than 15
Visual Analogue Scale (VAS)
Visual Analogue Scale: the changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value; The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
Secondary Outcome Measures
subjective symptoms
• subjective symptoms: dryness, itching, burning, dyspareunia, and dysuria reported on patient diary and scored as reported in the AGATA study as follows: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe intensity. The change in these variables will be evaluated from baseline to day 3, 7, 21, 30 (final visit).
objective signs in the vaginal mucosa
• objective signs in the vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae scored as reported in the AGATA study by Investigator as: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. The change in these variables will be evaluated from baseline to 30 day (final visit).
Vaginal pH
• Vaginal pH: it will be measured by the Investigators with a test strip delivered by Sponsor. The baseline values can be ≥ 5.0 (this was the minimum value need for vaginal atrophy diagnosis in AGATA study) to 9.0. The Investigator will insert the pH strip into the upper wall of the vagina and will consider the reading made while the strip is still damp. The change in the mean value of this outcome will be evaluated from baseline to 30 day (final visit).
Vaginal Trophism Maturation Value (MV)
• Vaginal Trophism Maturation Value (MV): This outcome will be obtained from the cellular count of the vaginal smears at baseline and at the 30 days visit. The samples will be fixed, stored, and sent in the local laboratory in Timisoara, Romania (address details in TMF) for staining (Papanicolaou technique) and subsequent analysis. Samples will be evaluated by one independent cytopathologist blinded to the treatment. The MV will be calculated according to the following formula: MV = [1x (% superficial cells)] + [0.6x (% intermediate cells)] + [0.2x (% parabasal cells)]. The comparison will be between baseline and 30 days values.
Female Sexual Function Index (FSFI)
• Female Sexual Function Index (FSFI) Romanian version, evaluated by Investigator and analysed considering the change from baseline to 30 days (final visit).
Sexual Function (SF 12)
• SF 12 (Romanian version) evaluated by Investigator and analysed considering the changing from baseline to 30 day (final visit).
Global Symptom Score (GSS)
• Global Symptom Score (GSS) a composite score of symptoms, will be obtained to assess the effect of treatment on all individual symptoms taken as a whole. It will be calculated by the addition of the intensity scores of all individual symptoms (range, 1-15: 1 = only mild vaginal dryness, 15 = all five symptoms severe in intensity). This outcome will be compared, by assessing the change from baseline visit to 30 days visit (final visit).
Patient Global Assessment of Safety (PGAS)
• Patient Global Assessment of Safety (PGAS): it will be reported by the subject at all visits and all phone contacts in the patient diary using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety.
Investigator Global Assessment of Safety (IGAS)
• Investigator Global Assessment of Safety (IGAS): it will be reported by the Investigator using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit, only.
AE, ADE, SAE, SADE
• AE, ADE, SAE, SADE: they will be reported by the Investigators according to the current legislation. All adverse events will be collected by Investigators at all visits and phone contacts and evaluated considering the change from baseline.
Full Information
NCT ID
NCT04245358
First Posted
January 27, 2020
Last Updated
May 6, 2021
Sponsor
Italfarmaco
Collaborators
Opera CRO, a TIGERMED Group Company
1. Study Identification
Unique Protocol Identification Number
NCT04245358
Brief Title
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Official Title
Open Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Ainara® Vaginal Gel, In Post-Menopausal Women Affected By Vaginal Dryness
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italfarmaco
Collaborators
Opera CRO, a TIGERMED Group Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.
Detailed Description
Detailed Description: This is an open, non-comparative, multicenter study that evaluates the performance and safety of the medical device Ainara.
In this study the investigators use polycarbophilic vaginal moisturizing gel (Ainara) for symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label, non-comparative, interventional multicenter study. The recently developed polycarbophilic, vaginal moisturizing gel (Ainara®) is widely used by gynaecologists in Europe to relieve vaginal dryness and related symptoms. Regarding the design choice, the adoption of a comparison versus placebo was not possible for technical reasons (the impossibility to use a real placebo without moisturizing effects).
The Research Question of the present study is the following: in a population of post-menopausal women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal moisturizing gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with the baseline condition?
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ainara
Arm Type
Other
Arm Description
Ainara is a class II medical device, already marketed in several EU countries. Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).
Intervention Type
Device
Intervention Name(s)
Ainara
Intervention Description
1g of gel per administration
Primary Outcome Measure Information:
Title
Vaginal Health Index (VHI)
Description
Vaginal Health Index: the changing from baseline to day 30 (final visit) for VHI mean value; The minim score is 5 and the maxim is is 25. For a patient to be included in study, the score must be lower than 15
Time Frame
30 days
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale: the changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value; The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
Time Frame
30 days
Secondary Outcome Measure Information:
Title
subjective symptoms
Description
• subjective symptoms: dryness, itching, burning, dyspareunia, and dysuria reported on patient diary and scored as reported in the AGATA study as follows: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe intensity. The change in these variables will be evaluated from baseline to day 3, 7, 21, 30 (final visit).
Time Frame
30 days
Title
objective signs in the vaginal mucosa
Description
• objective signs in the vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae scored as reported in the AGATA study by Investigator as: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. The change in these variables will be evaluated from baseline to 30 day (final visit).
Time Frame
30 days
Title
Vaginal pH
Description
• Vaginal pH: it will be measured by the Investigators with a test strip delivered by Sponsor. The baseline values can be ≥ 5.0 (this was the minimum value need for vaginal atrophy diagnosis in AGATA study) to 9.0. The Investigator will insert the pH strip into the upper wall of the vagina and will consider the reading made while the strip is still damp. The change in the mean value of this outcome will be evaluated from baseline to 30 day (final visit).
Time Frame
30 days
Title
Vaginal Trophism Maturation Value (MV)
Description
• Vaginal Trophism Maturation Value (MV): This outcome will be obtained from the cellular count of the vaginal smears at baseline and at the 30 days visit. The samples will be fixed, stored, and sent in the local laboratory in Timisoara, Romania (address details in TMF) for staining (Papanicolaou technique) and subsequent analysis. Samples will be evaluated by one independent cytopathologist blinded to the treatment. The MV will be calculated according to the following formula: MV = [1x (% superficial cells)] + [0.6x (% intermediate cells)] + [0.2x (% parabasal cells)]. The comparison will be between baseline and 30 days values.
Time Frame
30 days
Title
Female Sexual Function Index (FSFI)
Description
• Female Sexual Function Index (FSFI) Romanian version, evaluated by Investigator and analysed considering the change from baseline to 30 days (final visit).
Time Frame
30 days
Title
Sexual Function (SF 12)
Description
• SF 12 (Romanian version) evaluated by Investigator and analysed considering the changing from baseline to 30 day (final visit).
Time Frame
30 days
Title
Global Symptom Score (GSS)
Description
• Global Symptom Score (GSS) a composite score of symptoms, will be obtained to assess the effect of treatment on all individual symptoms taken as a whole. It will be calculated by the addition of the intensity scores of all individual symptoms (range, 1-15: 1 = only mild vaginal dryness, 15 = all five symptoms severe in intensity). This outcome will be compared, by assessing the change from baseline visit to 30 days visit (final visit).
Time Frame
30 days
Title
Patient Global Assessment of Safety (PGAS)
Description
• Patient Global Assessment of Safety (PGAS): it will be reported by the subject at all visits and all phone contacts in the patient diary using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety.
Time Frame
30 days
Title
Investigator Global Assessment of Safety (IGAS)
Description
• Investigator Global Assessment of Safety (IGAS): it will be reported by the Investigator using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit, only.
Time Frame
Time frame: 30 days
Title
AE, ADE, SAE, SADE
Description
• AE, ADE, SAE, SADE: they will be reported by the Investigators according to the current legislation. All adverse events will be collected by Investigators at all visits and phone contacts and evaluated considering the change from baseline.
Time Frame
30 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female have vagina so only female can have vagina disease.
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menopausal women (total cessation of menses for ≥ 1 year) according to the STRAW criteria, aged ≥ 50 to ≤ 70 years;
Diagnosis of vaginal dryness by:
Subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study
VHI < 15.
Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2;
Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Capable of and freely willing to provide written informed consent prior to participating in the study.
Exclusion Criteria:
Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
Genital bleeding.
Estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study).
Systemic estrogen therapy (it was permitted only if terminated at least 6 months before study).
Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study or be likely to lead to hospitalization during the course of the study.
Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
Known allergy to tested IMDs or its excipients.
Drug or alcohol abuse in the 12 months prior to Day 0.
Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liviu Cristian PĂTRAȘCU, MD
Organizational Affiliation
Fizio Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fizio Center
City
Timişoara
State/Province
Timis
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
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