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Metronidazole

Phase 1

Bacterial Vaginosis | Small molecule | Infectious Disease |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment579

FDA Designations

No designations recorded

Clinical trial landscape

Metronidazole · 2 trials · 2 indications

Phase 1 2
NCT01020396Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial VaginosisBacterial Vaginosis
COMPLETED579 Analytics
NCT01020877Bioavailability of Metronidazole Vaginal Gel in Healthy SubjectsHealthy
COMPLETED38 Analytics
PHASE1COMPLETED
Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
Bacterial Vaginosis
NCT01020396579
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PHASE1COMPLETED
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Healthy
NCT0102087738
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Study Endpoints

Primary Endpoints

Therapeutic cure rate of the subject at the Test-of-Cure Visit.
Visit 3
Incidence of Adverse Effects reported throughout the study.
29 Days
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Blood samples collected over a 60 hour period.

Bioequivalence based on Cmax.

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Blood samples collected over a 60 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Blood samples collected over a 60 hour period.

Bioequivalence based on AUC0-inf.

Secondary Endpoints

Therapeutic cure rate at the Post-Treatment Visit
Visit 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMetronidazole Vaginal Gel, 0.75% (Teva Pharmaceuticals, USA)
2ACTIVE_COMPARATORMetroGel-Vaginal® metronidazole vaginal gel, 0.75% (3M Pharmaceuticals)

Interventions

NameTypeDescription
MetronidazoleDRUGVaginal Gel, 0.75%
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Subjects must provide written informed consent prior to any study related procedures being performed. * Female subjects must have a clinical diagnosis of bacterial vaginosis, defined as having the presence of "clue cells" \> 20% of the total epithelia cells on microscopic exam...

Countries:United States
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