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

NCT04245358 | Completed

• 1 other identifier: DMS/18/AINARA/02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• subjective symptoms

  30 days

• objective signs in the vaginal mucosa

  30 days

• Vaginal pH

  30 days

• Vaginal Trophism Maturation Value (MV)

  30 days

• Female Sexual Function Index (FSFI)

  30 days

Study Arms (1)

Ainara

OTHER

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

Interventions

Ainara DEVICE

1g of gel per administration

Ainara

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Only female have vagina so only female can have vagina disease.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Italfarmaco: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Fizio Center

Timișoara, Timiș County, Romania

Location

MeSH Terms

Conditions

Vaginal Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Liviu Cristian PĂTRAȘCU, MD

  Fizio Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, non-comparative, interventional multicenter study. The recently developed polycarbophilic, vaginal moisturizing gel (Ainara®) is widely used by gynaecologists in Europe to relieve vaginal dryness and related symptoms. Regarding the design choice, the adoption of a comparison versus placebo was not possible for technical reasons (the impossibility to use a real placebo without moisturizing effects). The Research Question of the present study is the following: in a population of post-menopausal women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal moisturizing gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with the baseline condition?

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 28, 2020
• Study Start: September 20, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: May 10, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)