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Treatment of Bacterial Vaginosis (BV) With Tinidazole

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ClinicalTrials.gov Identifier: NCT00334633
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : June 23, 2011
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Jane Schwebke, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Vaginosis
Intervention Drug: tinidazole, metronidazole
Enrollment 593
Recruitment Details women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)
Pre-assignment Details  
Arm/Group Title Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Hide Arm/Group Description metronidazole 500 twice a day (BID) for 7 days; 197 participants tinidazole 500 BID for 7 days; 200 particpants tinidazole 1 gm BID for 7 days; 196 particpants
Period Title: Overall Study
Started 197 200 196
Completed 117 118 114
Not Completed 80 82 82
Arm/Group Title Metronidazole Tinidazole 500 mg Tinidazole 1 gm Total
Hide Arm/Group Description metronidazole 500 BID for 7 days; 197 participants tinidazole 500 BID for 7 days; 200 particpants tinidazole 1 gm BID for 7 days; 196 particpants Total of all reporting groups
Overall Number of Baseline Participants 197 200 196 593
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 200 participants 196 participants 593 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
197
 100.0%
200
 100.0%
196
 100.0%
593
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 197 participants 200 participants 196 participants 593 participants
28  (6.2) 28.3  (6.6) 28.5  (6.8) 28.3  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 200 participants 196 participants 593 participants
Female
197
 100.0%
200
 100.0%
196
 100.0%
593
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 197 participants 200 participants 196 participants 593 participants
197 200 196 593
1.Primary Outcome
Title Cure of Bacterial Vaginosis
Hide Description resolution of Amsel criteria for bacterial vaginosis
Time Frame one month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Hide Arm/Group Description:
metronidazole 500 BID for 7 days; 197 participants
tinidazole 500 BID for 7 days; 200 particpants
tinidazole 1 gm BID for 7 days; 196 particpants
Overall Number of Participants Analyzed 117 118 114
Measure Type: Number
Unit of Measure: participants
75 73 77
2.Secondary Outcome
Title Recurrence of BV
Hide Description [Not Specified]
Time Frame baseline to 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Tinidazole 500 Tinidazole 1 gm
Hide Arm/Group Description:

metronidazole 500 BID for 7 days

tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

tinidazole 500 BID for 7 days

tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

tinidazole 1 gm BID for 7 days

tinidazole, metronidazole: Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

Overall Number of Participants Analyzed 117 114 118
Measure Type: Count of Participants
Unit of Measure: Participants
42
  35.9%
45
  39.5%
37
  31.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Hide Arm/Group Description metronidazole 500 BID for 7 days; 197 participants tinidazole 500 BID for 7 days; 200 particpants tinidazole 1 gm BID for 7 days; 196 particpants
All-Cause Mortality
Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/197 (0.00%)      0/200 (0.00%)      0/196 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metronidazole Tinidazole 500 mg Tinidazole 1 gm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   87/197 (44.16%)      109/200 (54.50%)      145/196 (73.98%)    
Gastrointestinal disorders       
gastrointestinal   39/126 (30.95%)  39 54/161 (33.54%)  54 91/196 (46.43%)  91
Infections and infestations       
vaginal candidiasis   32/126 (25.40%)  32 33/161 (20.50%)  33 27/196 (13.78%)  27
Nervous system disorders       
headache   16/126 (12.70%)  16 22/161 (13.66%)  22 27/196 (13.78%)  27
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: jane R Schwebke, MD
Organization: University of Alabama at Birmingham
Phone: 205-975-5665
Responsible Party: Jane Schwebke, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00334633     History of Changes
Other Study ID Numbers: F040329003
R01AI058033 ( U.S. NIH Grant/Contract )
First Submitted: June 7, 2006
First Posted: June 8, 2006
Results First Submitted: March 3, 2011
Results First Posted: June 23, 2011
Last Update Posted: December 2, 2017