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)

  • 1 CSR Summary not Available
  • 1 NCT01867164
  • 1 Primary Citation Not Yet Available
  • Data Specification Not Available

Trial Information

Generic NameTerconazoleProduct NameTERAZOL ®Therapeutic AreaUrinary Tract, Sexual Organs, and Pregnancy ConditionsEnrollment160% FemaleN/A% WhiteN/A
Product ClassOB/GYNSponsor Protocol NumberTEROV8BAC4001Data PartnerJohnson & JohnsonCondition StudiedVaginitis Infectious VaginosisMean/Median Age (Years)N/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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