Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Italfarmaco

Status: Completed

Conditions: Vaginal Disease

Treatments: Device: Ainara

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04245358

DMS/18/AINARA/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Ainara

Other group

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).

Treatment:

Device: Ainara