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 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.

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Key information

Conditions

Vaginosis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100 mg clindamycin /800 mg ketoconazole vaginal ovule

Drug

1 vaginal ovule for 3 consecutive days

100 mg tetracycline hydrochloride /50 mg amphotericin B cream

Drug

1 applicator (4 g) full of cream intravaginally for 7 to 10 days

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 10, 2011
Registry last updated: Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed