Study Phase 3

A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT01867164
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameTerconazoleProduct NameTERAZOL ®Therapeutic AreaGenito Urinary System and Sex HormonesProduct ClassGynecological Anti-Infectives and AntisepticsPharmacological SubgroupAnti-Infectives and Antiseptics, excluding Combinations with CorticosteroidsChemical SubgroupTriazole DerivativesCondition StudiedVaginitis Infectious Vaginosis
Sponsor Protocol NumberTEROV8BAC4001Enrollment160Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)N/A% WhiteN/A

Supporting Documentation

  • Statistical Analysis Plan Available
  • Clinical Study Report Available
Additional Information

Please note: individual participant-level data are not available for this trial. Only the statistical analysis plan and full clinical study report are available.

Disclaimer

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