Vaginal Disease
Conditions
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.
Interventions
DEVICEAinara
1 g at each administration
Sponsors
Opera CRO, a TIGERMED Group Company
Italfarmaco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Women previously treated with Ainara® vaginal gel in the study DMS/18/AINARA/01 or DMS/18/AINARA/02. 2. 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. 3. 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); 4. Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2 5. Females of childbearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study. 6. Able to communicate adequately with the Investigator and to comply with the requirements for the entire study. 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Health Index (VHI) | 180 days | 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 | 180 days | 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 | 180 days | 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 | 180 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjective symptoms | 30, 60, 90, 120, 150, 180 days | 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 | 180 days | 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 | 180 days | 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) | 180 days | 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) | 90, 180 days | 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. |
Countries
Romania
Outcome results
None listed