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

Open Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Ainara® Vaginal Gel, In Post-Menopausal Women Affected By Vaginal Dryness

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Disease
• Intervention / Treatment: Device: Ainara

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timişoara, Timis, Romania
      • Fizio Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ainara; 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).	Device: Ainara; 1g of gel per administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	30 days
Vaginal Trophism Maturation Value (MV)	• Vaginal Trophism Maturation Value (MV): This outcome will be obtained from the cellular count of the vaginal smears at baseline and at the 30 days visit. The samples will be fixed, stored, and sent in the local laboratory in Timisoara, Romania (address details in TMF) for staining (Papanicolaou technique) and subsequent analysis. Samples will be evaluated by one independent cytopathologist blinded to the treatment. The MV will be calculated according to the following formula: MV = [1x (% superficial cells)] + [0.6x (% intermediate cells)] + [0.2x (% parabasal cells)]. The comparison will be between baseline and 30 days values.	30 days
Female Sexual Function Index (FSFI)	• Female Sexual Function Index (FSFI) Romanian version, evaluated by Investigator and analysed considering the change from baseline to 30 days (final visit).	30 days
Sexual Function (SF 12)	• SF 12 (Romanian version) evaluated by Investigator and analysed considering the changing from baseline to 30 day (final visit).	30 days
Global Symptom Score (GSS)	• Global Symptom Score (GSS) a composite score of symptoms, will be obtained to assess the effect of treatment on all individual symptoms taken as a whole. It will be calculated by the addition of the intensity scores of all individual symptoms (range, 1-15: 1 = only mild vaginal dryness, 15 = all five symptoms severe in intensity). This outcome will be compared, by assessing the change from baseline visit to 30 days visit (final visit).	30 days
Patient Global Assessment of Safety (PGAS)	• Patient Global Assessment of Safety (PGAS): it will be reported by the subject at all visits and all phone contacts in the patient diary using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety.	30 days
Investigator Global Assessment of Safety (IGAS)	• Investigator Global Assessment of Safety (IGAS): it will be reported by the Investigator using the 4-point scale: 1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit, only.	Time frame: 30 days
AE, ADE, SAE, SADE	• AE, ADE, SAE, SADE: they will be reported by the Investigators according to the current legislation. All adverse events will be collected by Investigators at all visits and phone contacts and evaluated considering the change from baseline.	30 days

Collaborators and Investigators

• Sponsor: Italfarmaco
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: Liviu Cristian PĂTRAȘCU, MD, Fizio Center

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): December 9, 2019
• Study Completion (Actual): December 9, 2019

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vaginal Diseases
• Other Study ID Numbers: DMS/18/AINARA/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No