Ignite Creation Date:
2025-12-18 @ 8:46 AM
Ignite Modification Date:
2025-12-23 @ 10:58 PM
Study NCT ID:
NCT04362371
Status:
None
Last Update Posted:
2021-05-11 00:00:00
First Post:
2020-01-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Marketing Follow Up Study To Evaluate Performance Safety Quality of Menopausal Transition Women Treated With Ainara
Sponsor:
None
Organization:
Study Overview
Official Title:
Post Marketing Follow Up Study To Evaluate Performance, Safety And Quality Of Life In Late Menopausal Transition And Post-Menopausal Women Treated With The Medical Device Ainara® Vaginal Gel, For Vaginal Dryness For 6 Months
Status:
None
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 menopausal transition and post-menopausal women treated with the medical device Ainara® vaginal gel for vaginal dryness for 6 months The Research Question of the present study is the following: in a population composed of menopausal transition and menopausal women treated with polycarbophilic vaginal gel (Ainara®) for vaginal dryness, will a 6-month post marketing follow up study be able to give a reliable overview on the long-term performance (in terms of VHI, subjective and objective symptoms, and female sexual function), safety (in terms of patient and Investigator evaluation, and potential unknown risks of ADE/SADE/USADE/AE/SAE) and quality of life of this medical device.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: