Clinical trial NCT04245358: Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Disease
Lead sponsor: Italfarmaco
Sponsor class: INDUSTRY
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2020-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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?
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal Health Index (VHI)
timeFrame: 30 days
measure: Visual Analogue Scale (VAS)
timeFrame: 30 days
Secondary outcomes:
measure: subjective symptoms
timeFrame: 30 days
measure: objective signs in the vaginal mucosa
timeFrame: 30 days
measure: Vaginal pH
timeFrame: 30 days
measure: Vaginal Trophism Maturation Value (MV)
timeFrame: 30 days
measure: Female Sexual Function Index (FSFI)
timeFrame: 30 days
measure: Sexual Function (SF 12)
timeFrame: 30 days
measure: Global Symptom Score (GSS)
timeFrame: 30 days
measure: Patient Global Assessment of Safety (PGAS)
timeFrame: 30 days
measure: Investigator Global Assessment of Safety (IGAS)
timeFrame: Time frame: 30 days
measure: AE, ADE, SAE, SADE
timeFrame: 30 days
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: Fizio Center
state: Timis
Study officials:
affiliation: Fizio Center
name: Liviu Cristian PĂTRAȘCU, MD
role: PRINCIPAL_INVESTIGATOR
References: