Back to resultsPost Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With 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:
- Women previously treated with Ainara® vaginal gel in the study DMS/18/AINARA/01 or DMS/18/AINARA/02.
- Non-pregnant and in late menopausal transition (with a break in menstrual periods of at least 60 days), or post-menopausal (total cessation of menses for ≥ 1 year) women following STRAW criteria and considering the screening date of the study (DMS/18/AINARA/01 or DMS/18/AINARA/02) in which they were enrolled.
- Women aged ≥ 45 to ≤ 70 years (considering the baseline date of the study DMS/18/AINARA/01 or DMS/18/AINARA/02 in which they were previously enrolled);
- Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2
- Females of childbearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
- 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:
Subjects fulfilling one or more of the following exclusion criteria will NOT be included in the study:
- Malignancy (also leukemic infiltrates) within 5 years prior to Day 1 (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.
- 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 12 months prior to Day 1.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days (except DMS/18/AINARA/01 or DMS/18/AINARA/02).
- 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
Experimental
Arm Label
Ainara
Arm Description
Ainara is a class II medical device, already marketed in several EU countries. The product is a mucoadhesive moisturising gel for vulvovaginal use, indicated for the relief of symptoms of vaginal atrophy and dryness, and related discomfort. In each packaging there is a tube containing the gel (sterile and viscous with about 87% water) and a syringe-like plastic applicator with cannula and plunger. 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)
To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: Vaginal Health Index (VHI) by Investigator. For outcome the change from baseline to Visit 2 (final visit) will be analyzed; Minimal value for VHI is 1 and maximal value for VHI is 5. A higher score on VHI means an improvement in vaginal health
Visual Analogue Scale (VAS) for vaginal dryness evaluated by subjects
To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: the Visual Analogue Scale (VAS) by the subject. For the VAS outcome the change from baseline to Visit 2 (final visit) will be analyzed; in addition, VAS mean value will be compared with the value at days 30, 60, 90, 120, and 150.
SF 12 questionnaire completed by the patient
Quality of Life will be evaluated by SF12 questionnaire, a binary (Yes/No) and multiple choice-type survey, widely used to assess general health. Data will be analyzed comparing scores from baseline visit to Visit 2 (final visit).
ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE
Safety will be evaluated by the collection of ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE, • ADE/SADE/USADE and AE/SAE; Patient Global evaluation of safety (PGAS); Investigator Global evaluation of safety (IGAS);
Secondary Outcome Measures
Rate of 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 days 30, 60, 90, 120, 150, and 180 (final visit).
Objective signs in vaginal mucosa
Objective signs in vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae evaluated by Investigator as: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. The change in these variables will be evaluated from baseline to Visit 2 (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 from 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. For this outcome the change of mean values will be analysed from baseline to Visit 2 (final visit).
Global Symptom Score (GSS)
Global Symptom Score (GSS)(20) 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 analysed assessing the change from baseline visit to day 180 visit (final visit).
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) Romanian version, evaluated by Investigator and analysed considering the change from baseline to 90 and 180 days (final visit). The minimum score of this scale is 19 and the maximum value is 95. A higher score means an improvement in sexual function of the subject.
Full Information
NCT ID
NCT04362371
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
NCT04362371
Brief Title
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
Official Title
Post Marketing Follow Up Study To Evaluate Performance, Safety And Quality Of Life In Late Menopausal Transition And Post-Menopausal Women Treated With The Medical Device Ainara® Vaginal Gel, For Vaginal Dryness For 6 Months
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 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
The objective of the present PMCF study with a 6 month follow up period is to identify potential new and unknown risks associated with longer term use of Ainara® and (considering the duration of symptoms in GSM) to collect additional data regarding efficacy of a long-term treatment with this medical device.
Detailed Description
This is an interventional prospective study. It fits/pertains into the category of Post Marketing Clinical Follow up studies. The study evaluates performance, safety, and quality of life in late menopausal transition and post-menopausal women treated with the medical device Ainara® vaginal gel for vaginal dryness for 6 months The Research Question of the present study is the following: in a population composed of menopausal transition and menopausal women treated with polycarbophilic vaginal gel (Ainara®) for vaginal dryness, will a 6-month post marketing follow up study be able to give a reliable overview on the long-term performance (in terms of VHI, subjective and objective symptoms, and female sexual function), safety (in terms of patient and Investigator evaluation, and potential unknown risks of ADE/SADE/USADE/AE/SAE) and quality of life of this medical device.
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
Post Marketing Follow Up Study.
Enrolled patients will be 75, divided as follows:
25 patients belonging to study DMS/18/AINARA/01 (only Arm A, Ainara®)
50 patients belonging to study DMS/18/AINARA/02
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ainara
Arm Type
Experimental
Arm Description
Ainara is a class II medical device, already marketed in several EU countries. The product is a mucoadhesive moisturising gel for vulvovaginal use, indicated for the relief of symptoms of vaginal atrophy and dryness, and related discomfort. In each packaging there is a tube containing the gel (sterile and viscous with about 87% water) and a syringe-like plastic applicator with cannula and plunger.
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
1 g at each administration
Primary Outcome Measure Information:
Title
Vaginal Health Index (VHI)
Description
To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: Vaginal Health Index (VHI) by Investigator. For outcome the change from baseline to Visit 2 (final visit) will be analyzed; Minimal value for VHI is 1 and maximal value for VHI is 5. A higher score on VHI means an improvement in vaginal health
Time Frame
180 days
Title
Visual Analogue Scale (VAS) for vaginal dryness evaluated by subjects
Description
To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: the Visual Analogue Scale (VAS) by the subject. For the VAS outcome the change from baseline to Visit 2 (final visit) will be analyzed; in addition, VAS mean value will be compared with the value at days 30, 60, 90, 120, and 150.
Time Frame
180 days
Title
SF 12 questionnaire completed by the patient
Description
Quality of Life will be evaluated by SF12 questionnaire, a binary (Yes/No) and multiple choice-type survey, widely used to assess general health. Data will be analyzed comparing scores from baseline visit to Visit 2 (final visit).
Time Frame
180 days
Title
ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE
Description
Safety will be evaluated by the collection of ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE, • ADE/SADE/USADE and AE/SAE; Patient Global evaluation of safety (PGAS); Investigator Global evaluation of safety (IGAS);
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Rate of 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 days 30, 60, 90, 120, 150, and 180 (final visit).
Time Frame
30, 60, 90, 120, 150, 180 days
Title
Objective signs in vaginal mucosa
Description
Objective signs in vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae evaluated by Investigator as: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. The change in these variables will be evaluated from baseline to Visit 2 (final visit).
Time Frame
180 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 from 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. For this outcome the change of mean values will be analysed from baseline to Visit 2 (final visit).
Time Frame
180 days
Title
Global Symptom Score (GSS)
Description
Global Symptom Score (GSS)(20) 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 analysed assessing the change from baseline visit to day 180 visit (final visit).
Time Frame
180 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 90 and 180 days (final visit). The minimum score of this scale is 19 and the maximum value is 95. A higher score means an improvement in sexual function of the subject.
Time Frame
90, 180 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female subjects can have a vaginal disease
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women previously treated with Ainara® vaginal gel in the study DMS/18/AINARA/01 or DMS/18/AINARA/02.
Non-pregnant and in late menopausal transition (with a break in menstrual periods of at least 60 days), or post-menopausal (total cessation of menses for ≥ 1 year) women following STRAW criteria and considering the screening date of the study (DMS/18/AINARA/01 or DMS/18/AINARA/02) in which they were enrolled.
Women aged ≥ 45 to ≤ 70 years (considering the baseline date of the study DMS/18/AINARA/01 or DMS/18/AINARA/02 in which they were previously enrolled);
Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2
Females of childbearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
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:
Subjects fulfilling one or more of the following exclusion criteria will NOT be included in the study:
Malignancy (also leukemic infiltrates) within 5 years prior to Day 1 (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.
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 12 months prior to Day 1.
Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days (except DMS/18/AINARA/01 or DMS/18/AINARA/02).
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 Patrascu, 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
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Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
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