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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347632
First Posted: May 4, 2011
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Annie Thurman, CONRAD
Results First Submitted: November 1, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
  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 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      35 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 33  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      35 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   35 


  Outcome Measures
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1.  Primary:   p24 Antigen Production in Tissue   [ Time Frame: 6 weeks ]

2.  Primary:   p24 Antigen Production at Baseline Versus After Treatment With Metronidazole   [ Time Frame: 30 days ]


  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



Responsible Party: Annie Thurman, CONRAD
ClinicalTrials.gov Identifier: NCT01347632     History of Changes
Other Study ID Numbers: D11115
First Submitted: April 15, 2011
First Posted: May 4, 2011
Results First Submitted: November 1, 2013
Results First Posted: August 26, 2014
Last Update Posted: November 21, 2017