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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Zodiac Produtos Farmaceuticos S.A..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00889356
First Posted: April 28, 2009
Last Update Posted: April 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zodiac Produtos Farmaceuticos S.A.
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Tolerability based on adverse events reports and patient's information [ Time Frame: 7 days ]
  • Safety based on adverse events reports and laboratory criterion [ Time Frame: 7 days ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos
ClinicalTrials.gov Identifier: NCT00889356     History of Changes
Other Study ID Numbers: ZD 002-08
First Submitted: April 24, 2009
First Posted: April 28, 2009
Last Update Posted: April 28, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Candidiasis
Vaginal Diseases
Vaginosis, Bacterial
Mycoses
Genital Diseases, Female
Bacterial Infections
Vaginitis
Ketoconazole
Amphotericin B
Liposomal amphotericin B
Clindamycin palmitate
Clindamycin phosphate
Clindamycin
Tetracycline
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents