Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03937869
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2019-04-22
Brief Title:
Evaluate the Safety of a Single Oral Dose of Solosec Secnidazole 2g for the Treatment of Adolescent Girls With BV
Sponsor:
Lupin Research Inc
Organization:
Lupin Research Inc
Study Overview
Official Title:
A Multi-Center Open-Label Study to Evaluate the Safety of a Single Oral Dose of Solosec Secnidazole 2g Oral Granules for the Treatment of Adolescent Girls With Bacterial Vaginosis
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-center open-label study to evaluate the treatment of one oral dose of 2g Solosec Secnidazole in adolescent girls with BV
Detailed Description:
This is a multi-center open-label study to evaluate the safety of Solosec in adolescent girls with bacterial vaginosis Approximately 40 patients will be enrolled Patients determined to be eligible at the Baseline Visit Day 1 will receive a single oral dose of Solosec granules containing 2 grams of secnidazole on Day 1 Patients will return to the site once between Days 7-14 for a test of cure TOC Visit A follow-up telephone call will be performed at Days 21-30 to assess the continued clinical response to treatment and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None