Status:
COMPLETED
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
Lead Sponsor:
Janssen-Cilag, S.A.
Conditions:
Vaginitis
Infectious Vaginosis
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nyst...
Detailed Description
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, par...
Eligibility Criteria
Inclusion
- Participants presenting clinical symptoms compatible with vaginitis/bacterial vaginosis, with any of the following symptoms being the reason for the consultation: pruritus (itchiness), vulvar burning, as well as presenting leukorrhea (a clear or white discharge from the vagina, consisting mainly of mucus) as an accompanying symptom
- Participant who agrees to return at the 7th and 13th day after starting the treatment
- Participant who agrees to abstain from sexual relations for the 13 days of the study
- Participant who have signed informed consent to participate in the study
Exclusion
- Participant with a known allergy to vaginal treatments
- Participants who have received treatment for the current condition in the 10 days before the date of inclusion, or is currently receiving antibiotics (drug used to stop or slow down the growth of germs), antifungals, anti-parasitics or systemic steroids
- Participant with suspected pregnancy or currently breastfeeding
- Participant who has received unknown drugs or experimental drugs within the 3 months before inclusion
- Participant known to be a carrier of a severe (very serious, life threatening) disease that alters the metabolism or excretion of the drugs used (liver or kidney disease)
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01867164
Start Date
December 1 2007
End Date
December 1 2008
Last Update
December 24 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
DF, Mexico City, Mexico
2
Mexico City, Mexico