Clinical trial NCT04245293: Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
Official title: Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device AINARA® Vaginal Gel Versus A Hyaluronic Acid-Based Gel In Late Menopausal Transition 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): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, comparative, multicenter study with two parallel group of subjects. The clinical investigation will be performed in three clinical sites.

The calculated sample size of subjects is 50 (25 subject for each arm). To obtain this number of evaluable subjects it will be needed to screen about 60 subjects (including 6 potential screening failure) and to enroll 54 subjects (estimating 4 subjects drop out). From the equal distribution per groups of treatment point of view, the minimum and maximum number of patients recommended for each of the three centers will be 8 and 25, respectively.

The research question is: in a population of menopausal transition women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with that occurred in a group of patients treated with a HA-based gel (HyaloGyn®)?
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The 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: 30 days
measure: Adverse Event, Adverse Device Event, Serious Adverse Event, Suspected Adverse Device Event
timeFrame: 30 days
Other outcomes:
Locations:
city: Timişoara
country: Romania
facility: Fizio Center
state: Timis
Study officials:
affiliation: Fizio Center
name: Liviu Cristian PĂTRAȘCU, Dr
role: PRINCIPAL_INVESTIGATOR
References: