Viewing Study NCT02605135


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Study NCT ID: NCT02605135
Status: COMPLETED
Last Update Posted: 2019-01-22
First Post: 2015-11-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Host Response to Pessaries in Microbial Communities of the Postmenopausal Vagina
Sponsor: Loyola University
Organization:

Study Overview

Official Title: Host Response to Pessaries in Microbial Communities of the Postmenopausal
Status: COMPLETED
Status Verified Date: 2019-01
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: The ability to determine the postmenopausal vaginal environment and the impact of pessary use could help to maximize pessary therapy and non-surgical treatment for such a prevalent problem.
Detailed Description: The study will advance the care of elderly patients through providing data to maximize non-surgical options to those at high risk for having surgery and its attending morbidity. In characterizing substantive differences in the vaginal environment of successful and unsuccessful pessary users, the investigators can identify elderly patients at higher risk of adverse events with pessary use as well as novel targets for the pharmacologic treatment of the altered vaginal microbiota and endogenous AMP levels, potentially allowing patients to continue with non-surgical therapies rather than pursuing surgical intervention.

Study Oversight

Has Oversight DMC: False
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?: