Vaginal Disease Clinical Trial
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04245358 -
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
|
N/A | |
Active, not recruiting |
NCT04664985 -
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.
|
N/A | |
Completed |
NCT04327947 -
Evaluation of Gynecological Acceptability of 3 Health Care Products
|
N/A | |
Recruiting |
NCT05587283 -
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women
|
Phase 1 | |
Completed |
NCT05888116 -
Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
|
N/A | |
Not yet recruiting |
NCT00890487 -
Hyaluronic Acid and Vaginal Distress
|
N/A | |
Completed |
NCT05817292 -
Study of the Vaginal Microbiota in Women Under Fertile Age
|
||
Completed |
NCT05872178 -
Omegia Softgel Clinical Research Program
|
N/A | |
Completed |
NCT04245293 -
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
|
N/A |