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)

Vaginosis, Bacterial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293643
• Other study ID #: P08077
• Secondary ID: BR 001-09
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2011
• Last updated: August 7, 2015
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants that obtain clinical cure		Baseline up to Day 10	No
Primary	Percentage of participants that obtain microbiological cure		Baseline up to Day 10	No