Clinical trial NCT04362371: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Disease
Lead sponsor: Italfarmaco
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2020-04-24
Enrollment: 73
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria will NOT be included in the study:

1. Malignancy (also leukemic infiltrates) within 5 years prior to Day 1 (except for treated basal cell/squamous cell carcinoma of the skin).
2. Genital bleeding.
3. Estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study).
4. Systemic estrogen therapy (it was permitted only if terminated at least 6 months before study).
5. 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.
6. 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).
7. Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
8. Known allergy to tested IMDs or its excipients.
9. Drug or alcohol abuse 12 months prior to Day 1.
10. 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).
11. Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.

Primary outcomes:
measure: Vaginal Health Index (VHI)
timeFrame: 180 days
measure: Visual Analogue Scale (VAS) for vaginal dryness evaluated by subjects
timeFrame: 180 days
measure: SF 12 questionnaire completed by the patient
timeFrame: 180 days
measure: ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE
timeFrame: 180 days
Secondary outcomes:
measure: Rate of subjective symptoms
timeFrame: 30, 60, 90, 120, 150, 180 days
measure: Objective signs in vaginal mucosa
timeFrame: 180 days
measure: Vaginal pH
timeFrame: 180 days
measure: Global Symptom Score (GSS)
timeFrame: 180 days
measure: Female Sexual Function Index (FSFI)
timeFrame: 90, 180 days
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: Fizio Center
state: Timis
Study officials:
affiliation: Fizio Center
name: Liviu Cristian Patrascu, MD
role: PRINCIPAL_INVESTIGATOR
References: