Safety and Efficacy Study to Treat Bacterial Vaginosis

Medicis Global Service

Status and phase: Completed; Phase 3

Conditions: Bacterial Vaginosis

Treatments: Drug: Placebo Vehicle (non-treatment); Drug: Product 55394

Study type: Interventional

Funder types: Industry

Identifiers

NCT01621399

MP-1601-01

Details and patient eligibility

About

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

Enrollment: 651 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of bacterial vaginosis as determined by the investigator.
• Other items as identified in the protocol.

Exclusion criteria

• Have a known or suspected other infectious cause of vulvovaginitis.
• Other items as identified in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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651 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Treatment with the vehicle (placebo)

Treatment:

Drug: Placebo Vehicle (non-treatment)

Product 55394

Experimental group

Description:

Treatment with product 55394

Treatment:

Drug: Product 55394