Safety and Efficacy Study to Treat Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of Product 55394 in the Treatment of Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621399
• Other study ID #: MP-1601-01
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2012
• Last updated: August 20, 2013
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Product 55394
Product 55394 vaginal gel in a prefilled applicator.
• Placebo Vehicle (non-treatment)
The vehicle vaginal gel in an applicator (placebo).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure	The proportion of subjects with a clinical cure at the Day 21 visit, as assessed by the investigator.	Day 21	No
Secondary	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.	Day 21	No