Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

Bacterial Vaginosis Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00889356
• Other study ID #: ZD 002-08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 24, 2009
• Last updated: April 27, 2009
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2009
• Source: Zodiac Produtos Farmaceuticos S.A.
• Contact: Rogerio Bonassi Machado, MD
• Phone: +55 11 4521-6466
• Email: rogeriobonassi[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Mixed-type vaginosis

• Bacterial vaginosis

• Candidiasis

Exclusion Criteria:

• Pregnancy

• Vaginal bleeding

• History of recurrent vaginosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Clindamycin 100mg and Ketoconazole 400mg
1 vaginal capsule once a day at night
• Tetracycline 100mg and Amphotericin B 50mg
One full applicator, once a day at night

Locations

Country	Name	City	State
Brazil	Vox Femina	Jundiaí	SP

Sponsors (1)

Lead Sponsor	Collaborator
Zodiac Produtos Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy based on cure rate evaluated by clinical and laboratory criteria.		7 days	Yes
Secondary	Tolerability based on adverse events reports and patient's information		7 days	Yes
Secondary	Safety based on adverse events reports and laboratory criterion		7 days	Yes