Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 3:08 AM
Study NCT ID:
NCT00889356
Status:
UNKNOWN
Last Update Posted:
2009-04-28
First Post:
2009-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Sponsor:
Zodiac Produtos Farmaceuticos S.A.
Organization:
Study Overview
Official Title:
Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
Status:
UNKNOWN
Status Verified Date:
2009-04
Last Known Status:
NOT_YET_RECRUITING
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 determine the Efficacy, Tolerability \& Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: