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

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ClinicalTrials.gov Identifier: NCT01347632
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : August 26, 2014
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Annie Thurman, CONRAD

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
Enrollment 35
Recruitment Details Recruitment for 6 months
Pre-assignment Details  
Arm/Group Title Metronidazole
Hide Arm/Group Description Open Label Study
Period Title: Overall Study
Started 35
Completed 33
Not Completed 2
Arm/Group Title Metronidazole
Hide Arm/Group Description Open Label Study
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
33  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
35
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title p24 Antigen Production in Tissue
Hide Description

The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:

  1. During a BV infection
  2. Approximately 1 week after completing a 7-day course of metronidazole therapy
  3. Approximately 1 month after completing the 7-day course of metronidazole therapy

Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected.

Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metronidazole
Hide Arm/Group Description:
Open Label Study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title p24 Antigen Production at Baseline Versus After Treatment With Metronidazole
Hide Description p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metronidazole
Hide Arm/Group Description:
Open Label Study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metronidazole
Hide Arm/Group Description Open Label Study
All-Cause Mortality
Metronidazole
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metronidazole
Affected / at Risk (%) # Events
Total   0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metronidazole
Affected / at Risk (%) # Events
Total   2/35 (5.71%)    
Gastrointestinal disorders   
Nausea * 1 [1]  2/35 (5.71%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Other
[1]
Nausea is commonly associated with metronidazole treatment
There were no serious adverse events related to product or procedures.
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
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: December 19, 2017