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Search / Trial NCT01293643

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)

Launched by MERCK SHARP & DOHME LLC · Feb 9, 2011

Trial Information

Current as of April 28, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility 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

About Merck Sharp & Dohme Llc

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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