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

NCT ID: NCT04245293

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2019-11-22

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.

Conditions

Vaginal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ainara

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).

Group Type: EXPERIMENTAL

Ainara

Intervention Type: DEVICE

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).

HyaloGin

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).

Group Type: ACTIVE_COMPARATOR

HyaloGin

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

HyaloGin

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

Italfarmaco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liviu Cristian PĂTRAȘCU, Dr

Role: PRINCIPAL_INVESTIGATOR

Fizio Center

Locations

Fizio Center

Timișoara, Timiș County, Romania

Countries

Romania

Other Identifiers

DMS/18/AINARA/01

Identifier Type: -

Identifier Source: org_study_id