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

Italfarmaco50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginal Disease

Interventions

AinaraDEVICE

1g of gel per administration

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fizio Center

Timișoara, Timiș County, Romania

Outcomes

Primary Outcomes

Vaginal Health Index (VHI)

Vaginal Health Index: the changing from baseline to day 30 (final visit) for VHI mean value; The minim score is 5 and the maxim is is 25. For a patient to be included in study, the score must be lower than 15

Time frame: 30 days

Visual Analogue Scale (VAS)

Visual Analogue Scale: the changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value; The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms

Time frame: 30 days

Secondary Outcomes

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 day 3, 7, 21, 30 (final visit).

Time frame: 30 days

objective signs in the vaginal mucosa

• objective signs in the vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae scored as reported in the AGATA study by Investigator as: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. The change in these variables will be evaluated from baseline to 30 day (final visit).

Time frame: 30 days

Vaginal pH

• Vaginal pH: it will be measured by the Investigators with a test strip delivered by Sponsor. The baseline values can be ≥ 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. The change in the mean value of this outcome will be evaluated from baseline to 30 day (final visit).

Time frame: 30 days

Data from ClinicalTrials.gov

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