A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis

PHASE3CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
VaginitisInfectious Vaginosis
Interventions
DRUG

Gynoclin V

One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.

DRUG

Vagitrol V

One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.

Trial Locations (2)

Unknown

DF

Mexico City

All Listed Sponsors
lead

Janssen-Cilag, S.A.

INDUSTRY

NCT01867164 - A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis | Biotech Hunter | Biotech Hunter