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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by Zodiac Produtos Farmaceuticos S.A.. Recruitment status was Not yet recruiting

First Received on April 24, 2009. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: Clindamycin 100mg and Ketoconazole 400mg	Drug: Clindamycin 100mg and Ketoconazole 400mg 1 vaginal capsule once a day at night
Active Comparator: Tetracycline 100mg and Amphotericin B 50mg	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
Vox Femina	Not yet recruiting
Jundiaí, SP, Brazil
Contact: Rogerio Bonassi Machado, MD
Principal Investigator: Rogerio Bonassi Machado, MD

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

Additional relevant MeSH terms:

Candidiasis
Vaginosis, Bacterial
Mycoses
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Tetracycline
Clindamycin
Amphotericin B
Clindamycin-2-phosphate
Liposomal amphotericin B
Ketoconazole

Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
14-alpha Demethylase Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012