Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara

NCT04362371 | Completed

• 1 other identifier: DMS/18/AINARA/03
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present PMCF study with a 6 month follow up period is to identify potential new and unknown risks associated with longer term use of Ainara® and (considering the duration of symptoms in GSM) to collect additional data regarding efficacy of a long-term treatment with this medical device.

Conditions

Vaginal Disease

Outcome Measures

Primary Outcomes (4)

• Vaginal Health Index (VHI)

  To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: Vaginal Health Index (VHI) by Investigator. For outcome the change from baseline to Visit 2 (final visit) will be analyzed; Minimal value for VHI is 1 and maximal value for VHI is 5. A higher score on VHI means an improvement in vaginal health

  180 days

• Visual Analogue Scale (VAS) for vaginal dryness evaluated by subjects

  To measure the Ainara®'s efficacy on vaginal dryness the same outcomes used in the two trials DMS/18/AINARA/01 and DMS/18/AINARA/02 were chosen: the Visual Analogue Scale (VAS) by the subject. For the VAS outcome the change from baseline to Visit 2 (final visit) will be analyzed; in addition, VAS mean value will be compared with the value at days 30, 60, 90, 120, and 150.

  180 days

• SF 12 questionnaire completed by the patient

  Quality of Life will be evaluated by SF12 questionnaire, a binary (Yes/No) and multiple choice-type survey, widely used to assess general health. Data will be analyzed comparing scores from baseline visit to Visit 2 (final visit).

  180 days

• ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE

  Safety will be evaluated by the collection of ADE/SADE/USADE (adverse device event, serious adverse device event unexpected serious device event) and AE/SAE, • ADE/SADE/USADE and AE/SAE; Patient Global evaluation of safety (PGAS); Investigator Global evaluation of safety (IGAS);

  180 days

Secondary Outcomes (5)

• Rate of subjective symptoms

  30, 60, 90, 120, 150, 180 days

• Objective signs in vaginal mucosa

  180 days

• Vaginal pH

  180 days

• Global Symptom Score (GSS)

  180 days

• Female Sexual Function Index (FSFI)

  90, 180 days

Study Arms (1)

Ainara

EXPERIMENTAL

Ainara is a class II medical device, already marketed in several EU countries. The product is a mucoadhesive moisturising gel for vulvovaginal use, indicated for the relief of symptoms of vaginal atrophy and dryness, and related discomfort. In each packaging there is a tube containing the gel (sterile and viscous with about 87% water) and a syringe-like plastic applicator with cannula and plunger. 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

Interventions

Ainara DEVICE

1 g at each administration

Ainara

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Only female subjects can have a vaginal disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women previously treated with Ainara® vaginal gel in the study DMS/18/AINARA/01 or DMS/18/AINARA/02.
• Non-pregnant and in late menopausal transition (with a break in menstrual periods of at least 60 days), or post-menopausal (total cessation of menses for ≥ 1 year) women following STRAW criteria and considering the screening date of the study (DMS/18/AINARA/01 or DMS/18/AINARA/02) in which they were enrolled.
• Women aged ≥ 45 to ≤ 70 years (considering the baseline date of the study DMS/18/AINARA/01 or DMS/18/AINARA/02 in which they were previously enrolled);
• Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2
• Females of childbearing 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:

• Malignancy (also leukemic infiltrates) within 5 years prior to Day 1 (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.
• 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 12 months prior to Day 1.
• Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days (except DMS/18/AINARA/01 or DMS/18/AINARA/02).

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 Patrascu, MD

  Fizio Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Post Marketing Follow Up Study. Enrolled patients will be 75, divided as follows: * 25 patients belonging to study DMS/18/AINARA/01 (only Arm A, Ainara®) * 50 patients belonging to study DMS/18/AINARA/02

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: April 24, 2020
• Study Start: June 27, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: May 11, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)