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

This study has been completed.
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Annie Thurman, CONRAD
ClinicalTrials.gov Identifier:
NCT01347632
First received: April 15, 2011
Last updated: August 12, 2014
Last verified: August 2014
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
NA

Reporting Groups
  Description
Metronidazole Open Label Study

Participant Flow:   Overall Study
    Metronidazole  
STARTED     35  
COMPLETED     33  
NOT COMPLETED     2  



  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.
No text entered.

Reporting Groups
  Description
Metronidazole Open Label Study

Baseline Measures
    Metronidazole  
Number of Participants  
[units: participants]
  35  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     35  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  33  ± 2  
Gender  
[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
e-mail: thurmaar@evms.edu


No publications provided


Responsible Party: Annie Thurman, CONRAD
ClinicalTrials.gov Identifier: NCT01347632     History of Changes
Other Study ID Numbers: D11115
Study First Received: April 15, 2011
Results First Received: November 1, 2013
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board