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Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue (CONRADBV)

This study has been completed.
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Annie Thurman, CONRAD Identifier:
First received: April 15, 2011
Last updated: January 28, 2016
Last verified: January 2016
Results First Received: November 1, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Bacterial Vaginosis
Vaginal Discharge
Intervention: Drug: Metronidazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment for 6 months

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Metronidazole Open Label Study

Participant Flow:   Overall Study

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Metronidazole Open Label Study

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   35 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 33  (2) 
[Units: Participants]
Female   35 
Male   0 
Region of Enrollment 
[Units: Participants]
United States   35 

  Outcome Measures

1.  Primary:   p24 Antigen Concentration ng/mL   [ Time Frame: 6 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no serious adverse events related to product or procedures.

  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Andrea Thurman
Organization: CONRAD
phone: 757-446-7444

Responsible Party: Annie Thurman, CONRAD Identifier: NCT01347632     History of Changes
Other Study ID Numbers: D11115
Study First Received: April 15, 2011
Results First Received: November 1, 2013
Last Updated: January 28, 2016