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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:
ClinicalTrials.gov Identifier:
NCT01293643
First Posted: February 10, 2011
Last Update Posted: August 10, 2015
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 (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants that obtain clinical cure [ Time Frame: Baseline up to Day 10 ]
  • Percentage of participants that obtain microbiological cure [ Time Frame: Baseline up to Day 10 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01293643     History of Changes
Other Study ID Numbers: P08077
BR 001-09 ( Other Identifier: Schering Study Number )
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: August 10, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Candidiasis
Vaginal Diseases
Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Mycoses
Genital Diseases, Female
Bacterial Infections
Vaginitis
Vulvovaginitis
Vulvitis
Vulvar Diseases
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