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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01293643
First received: February 9, 2011
Last updated: August 7, 2015
Last verified: August 2015
  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: 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

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
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, see Learn About Clinical Studies.

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 )
Study First Received: February 9, 2011
Last Updated: August 7, 2015

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

ClinicalTrials.gov processed this record on June 23, 2017