Status:
COMPLETED
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
Lead Sponsor:
Italfarmaco
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Vaginal Disease
Eligibility:
FEMALE
45-70 years
Phase:
NA
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 sympt...
Detailed Description
This is an interventional prospective study. It fits/pertains into the category of Post Marketing Clinical Follow up studies. The study evaluates performance, safety, and quality of life in late menop...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Subjects fulfilling one or more of the following exclusion criteria will NOT be included in the study:
- 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).
- Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04362371
Start Date
June 27 2019
End Date
December 9 2019
Last Update
May 11 2021
Active Locations (1)
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1
Fizio Center
Timișoara, Timiș County, Romania