Vaginal Infection Study

Lumara Health

Status and phase: Completed; Phase 3

Conditions: Vaginitis; Vulvovaginitis

Treatments: Drug: clindamycin phosphate; Drug: clindamycin phosphate/butoconazole nitrate; Drug: butoconazole nitrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616330

CBC-302-602-622467

Details and patient eligibility

About

This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.

Enrollment: 1,443 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must have a clinical diagnosis of vaginal infection.
• Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.

Exclusion criteria

• Patients must not have any other infections
• May not be pregnant or nursing
• May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,443 participants in 3 patient groups

1

Experimental group

Description:

clindamycin phosphate/butoconazole nitrate

Treatment:

Drug: clindamycin phosphate/butoconazole nitrate

2

Active Comparator group

Description:

clindamycin phosphate

Treatment:

Drug: clindamycin phosphate

3

Active Comparator group

Description:

butoconazole nitrate

Treatment:

Drug: butoconazole nitrate