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

NCT04245293 | Completed

• 1 other identifier: DMS/18/AINARA/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaginal Disease

Outcome Measures

Primary Outcomes (2)

• The Vaginal Health Index (VHI)

  The changing from baseline to day 30 (final visit) for VHI mean value in each group separately and the changing in the Ainara® group in comparison with that occurred in HyaloGyn® group; The minim score is 5 and the maxim is is 25

  30 days

• Visual Analogue Scale (VAS)

  The changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value in each group separately and in the Ainara® group in comparison with that occurred in HyaloGyn® group. 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 (2)

Ainara

EXPERIMENTAL

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).

Device: Ainara

HyaloGin

ACTIVE COMPARATOR

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).

Device: HyaloGin

Interventions

Ainara 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).

Ainara

HyaloGin 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).

HyaloGin

Eligibility Criteria

• Age: 45 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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, Dr

  Fizio Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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®)?

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 28, 2020
• Study Start: April 11, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)