Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara

Italfarmaco

Status: Completed

Conditions: Vaginal Disease

Treatments: Device: Ainara

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04362371

DMS/18/AINARA/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Ainara

Experimental group

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).

Treatment:

Device: Ainara