check_circleStudy Completed

Vaginitis

Bayer Identifier:

91148

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to evaluate the efficacy, safety and acceptance of a once a day application of a vaginal ovule or vaginal cream containing different active ingredients in patients with candidal, bacterial, trichomonal or mixed vaginitis

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal
476
Trial Dates
March 2003 - November 2003
Phase
Phase 3
Could I Receive a placebo
N/A
Products
Gynotran (Metronidazole, BAY86-5276)
Accepts Healthy Volunteer
N/A

Primary Outcome

Secondary Outcome

Trial design

Comparative, open, randomized, reference controlled study to evaluate the efficacy, safety and acceptance of a once a day application of a vaginal ovule SH AR 1570 or vaginal cream SH AR 1580 containing metronidazole 750 mg and miconazole nitrate 200 mg (each ovule/vaginal cream dose) for 7 days vs. Vaginal ovule containing tinidazole 150 mg and miconazole nitrate 400 mg each ovule for 8 days or vaginal cream, containing tinidazole 150 mg and miconazole nitrate 100 mg each vaginal cream dose for 7 days in 400 patients with candidal, bacterial, trichomonal or mixed vaginitis
Trial Type
Interventional
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.