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 12, 2014
Last verified: August 2014
  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:


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 ] [ 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
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

No publications provided

Responsible Party: 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: August 12, 2014
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Candidiasis
Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Mycoses
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvovaginitis
Vulvitis
Vulvar Diseases
Ketoconazole
Amphotericin B
Liposomal amphotericin B
Clindamycin palmitate
Clindamycin phosphate
Clindamycin
Tetracycline
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 16, 2014