Safety and Efficacy Study to Treat Bacterial Vaginosis

Medicis Global Service Corporation651 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

651

Conditions

Bacterial Vaginosis

Interventions

Product 55394DRUG

Product 55394 vaginal gel in a prefilled applicator.

Placebo Vehicle (non-treatment)DRUG

The vehicle vaginal gel in an applicator (placebo).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

Clinical Cure

The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.

Time frame: Day 21

Secondary Outcomes

Therapeutic Cure

The proportion of subjects with a therapeutic cure at the Day 21 visit. Therapeutic cure is defined as both a clinical cure and bacteriological cure as assessed by the investigator and the central laboratory, respectively.

Time frame: Day 21

Data from ClinicalTrials.gov

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