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NCT01867164 - 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 Versu

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)


CSR Summary

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Primary Citation

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Terconazole
Product Name
TERAZOL ®
Therapeutic Area
Urinary Tract, Sexual Organs, and Pregnancy Conditions
Enrollment
160
% Female
N/A
% White
N/A
Product Class
OB/GYN
Sponsor Protocol Number
TEROV8BAC4001
Data Holder
Johnson & Johnson
Condition Studied
Vaginitis Infectious Vaginosis
Mean/Median Age (Years)
N/A

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Statistical Analysis Plan
Study Phase 
3
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

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.