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

This study is not yet open for participant recruitment.

Verified by Zodiac Produtos Farmaceuticos S.A., April 2009

First Received: April 24, 2009 Last Updated: April 27, 2009 History of Changes

Sponsor:	Zodiac Produtos Farmaceuticos S.A.
Information provided by:	Zodiac Produtos Farmaceuticos S.A.
ClinicalTrials.gov Identifier:	NCT00889356

Purpose

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.

Condition	Intervention	Phase
Candidiasis Bacterial Vaginosis	Drug: Clindamycin 100mg and Ketoconazole 400mg Drug: Tetracycline 100mg and Amphotericin B 50mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Tetracycline Tetracycline hydrochloride Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Ketoconazole Fungarest Amphotericin B

U.S. FDA Resources

Further study details as provided by Zodiac Produtos Farmaceuticos S.A.:

Primary Outcome Measures:

Efficacy based on cure rate evaluated by clinical and laboratory criteria. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerability based on adverse events reports and patient's information [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Safety based on adverse events reports and laboratory criterion [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Clindamycin 100mg and Ketoconazole 400mg: Experimental	Drug: Clindamycin 100mg and Ketoconazole 400mg 1 vaginal capsule once a day at night
Tetracycline 100mg and Amphotericin B 50mg: Active Comparator	Drug: Tetracycline 100mg and Amphotericin B 50mg One full applicator, once a day at night

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mixed-type vaginosis
Bacterial vaginosis
Candidiasis

Exclusion Criteria:

Pregnancy
Vaginal bleeding
History of recurrent vaginosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889356

Contacts

Contact: Rogerio Bonassi Machado, MD	+55 11 4521-6466	rogeriobonassi@terra.com.br
Contact: Paula Fabrini, MD	+55 11 4521-6466

Locations

Brazil, SP
Vox Femina
Jundiaí, SP, Brazil

Sponsors and Collaborators

Zodiac Produtos Farmaceuticos S.A.

Investigators

Principal Investigator:

Rogerio Bonassi Machado, MD

CRM Regional Council of Medicine

More Information

No publications provided

Responsible Party:	Zodiac Produtos Farmaceuticos ( Julio Cesar Nophal de Carvalho )
Study ID Numbers:	ZD 002-08
Study First Received:	April 24, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00889356 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Abelcet
Bacterial Infections
Anti-Infective Agents
Clindamycin
Antiprotozoal Agents
Candidiasis
Molecular Mechanisms of Pharmacological Action
Vaginitis
Vaginal Diseases
Liposomal amphotericin B
Tetracycline
Genital Diseases, Female
Mycoses

Anti-Bacterial Agents
Antiparasitic Agents
Vaginosis, Bacterial
Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Amebicides
Amphotericin B
Clindamycin-2-phosphate
Enzyme Inhibitors
Ketoconazole
Pharmacologic Actions
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010