Viewing Study NCT01599416



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Last Modification Date: 2024-10-26 @ 10:51 AM
Study NCT ID: NCT01599416
Status: COMPLETED
Last Update Posted: 2018-01-05
First Post: 2012-05-07

Brief Title: Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: Randomized Double-blind Placebo-controlled Study Oral U-relax in the Influence of the Vaginal Environment Health Promotion and the HPV DNA Test Index Change From Positive to Negative on the HPV Infection Women
Status: COMPLETED
Status Verified Date: 2012-04
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 purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion and the HPV DNA Test Index change from positive to negative Long-term infection of HPV is associated with cervical cancer U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV UTI IBD and can improve vaginal environment health Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result
Detailed Description: This study is a prospective double blind randomized clinical trial Vaginal health screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after conization for 6 months All these patients will participant this study during the 360-day trial period All health related conditions will be monitored at the same time

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?: None
Secondary IDs
Secondary ID Type Domain Link
99-0948A3 OTHER CGMH None