Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-02-28 @ 10:51 PM
Study NCT ID:
NCT02180100
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Sponsor:
Peking University Shenzhen Hospital
Organization:
Study Overview
Official Title:
A Randomized, Parallel-group Study of Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe
Status:
COMPLETED
Status Verified Date:
2020-10
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 objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
Detailed Description:
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.
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?: