Status:
COMPLETED
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Lead Sponsor:
Padagis LLC
Conditions:
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product...
Eligibility Criteria
Inclusion
- Female at least 18 years of age
- Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.
Exclusion
- History of hypersensitivity or allergy to imidazoles
- Female who was pregnant or lactating
- Was menstruating or expected the onset of menses during the treatment days
- Had evidence of any bacterial, viral or protozoal infection
- Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
- Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
- Had participated in any investigational study within 30 days prior to study enrollment
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT00803738
Start Date
December 1 2002
End Date
December 1 2003
Last Update
October 13 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.