A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT01293643

First received: February 9, 2011

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Purpose

This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.

Condition	Intervention	Phase
Vaginosis, Bacterial Candidiasis, Vulvovaginal	Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Tetracycline Tetracycline hydrochloride Amphotericin B Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Ketoconazole Liposomal Amphotericin B

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Percentage of participants that obtain clinical cure [ Time Frame: Baseline up to Day 10 ] [ Designated as safety issue: No ]
Percentage of participants that obtain microbiological cure [ Time Frame: Baseline up to Day 10 ] [ Designated as safety issue: No ]

Enrollment:	99
Study Start Date:	May 2010
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: clindamycin/ketoconazole combination	Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule 1 vaginal ovule for 3 consecutive days
Active Comparator: tetracycline hydrochloride/amphotericin B combination	Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream 1 applicator (4 g) full of cream intravaginally for 7 to 10 days

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of vaginal candidiasis
No Trichomonas vaginalis or any other protozoa
No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria:

Known sensitivity to the formula components
Pregnant or nursing patients
Any gynecological condition contraindicating the use of vaginal ovule or cream.
Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
Presence of other sexually transmitted diseases (except from Candidal vaginitis).
History of recurrent candidiasis (≥4 episodes per year)
Use of intra-uterine device, spermicides, or diaphragms
Has metabolic or immune disorder
Has abnormal uterine bleeding

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01293643 History of Changes
Other Study ID Numbers:	P08077, BR 001-09
Study First Received:	February 9, 2011
Last Updated:	March 1, 2011
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Vaginosis, Bacterial
Bacterial Infections
Anti-Bacterial Agents
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Tetracycline
Clindamycin
Amphotericin B

Clindamycin-2-phosphate
Liposomal amphotericin B
Ketoconazole
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
14-alpha Demethylase Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013

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