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

Italfarmaco

Status: Completed

Conditions: Vaginal Disease

Treatments: Device: Ainara; Device: HyaloGin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04245293

DMS/18/AINARA/01

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Ainara

Experimental group

Description:

Experimental: Ainara 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).

Treatment:

Device: Ainara

HyaloGin

Active Comparator group

Description:

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).

Treatment:

Device: HyaloGin