Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

Italfarmaco50 enrolled

Overview

This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness

This is an open, comparative, multicenter study that evaluates the performance and safety of the medical device Ainara®. In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue Scale.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginal Disease

Interventions

AinaraDEVICE

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).

HyaloGinDEVICE

Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger. The gel quantity is enough for one subject (3g application every three days over the course of the study).

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-pregnant and in menopausal transition period (late peri-menopause) women following the STRAW criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years. * Diagnosis of vaginal dryness by subjective dryness, any objective sign of VVA, pH\>5 as reported in the AGATA study and VHI \< 15. * Body mass index of ≥ 18.5 to ≤ 36 kg/m2. * Females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study. * 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: * Women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit). * 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 (permitted only if terminated at least 6 months before study). * Systemic estrogen therapy (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 course of the study. * Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, 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 within 12 months of 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

The Vaginal Health Index (VHI)

The changing from baseline to day 30 (final visit) for VHI mean value in each group separately and the changing in the Ainara® group in comparison with that occurred in HyaloGyn® group; The minim score is 5 and the maxim is is 25

Time frame: 30 days

Visual Analogue Scale (VAS)

The changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value in each group separately and in the Ainara® group in comparison with that occurred in HyaloGyn® group. 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 as follows: 0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. For these variables will be evaluated the changing from baseline to day 3, 7, 21, 30 (final visit) with comparison intra and inter groups.

Time frame: 30 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 will be analysed the changing of mean values from baseline to 30 day (final visit) with comparison intra and inter groups.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.