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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)

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. Identifier: NCT01293643
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : August 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
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

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

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

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

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01293643    
Other Study ID Numbers: P08077
BR 001-09 ( Other Identifier: Schering Study Number )
First Posted: February 10, 2011    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vulvar Diseases
Amphotericin B
Liposomal amphotericin B
Clindamycin palmitate
Clindamycin phosphate
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