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Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

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ClinicalTrials.gov Identifier: NCT00545181
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : January 7, 2010
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Vaginosis
Interventions Drug: Vaginal acidifying gel (RepHresh)
Drug: Metronidazole control
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone
Hide Arm/Group Description Receive metronidazole plus vaginal acidifying gel Metronidazole antibiotic therapy alone
Period Title: Overall Study
Started 29 25
Completed 29 25
Not Completed 0 0
Arm/Group Title Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone Total
Hide Arm/Group Description Receive metronidazole plus vaginal acidifying gel Metronidazole antibiotic therapy alone Total of all reporting groups
Overall Number of Baseline Participants 29 25 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
25
 100.0%
54
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 25 participants 54 participants
29.8  (5.8) 32.4  (6.9) 31.0  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 25 participants 54 participants
Female
29
 100.0%
25
 100.0%
54
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 25 participants 54 participants
29 25 54
1.Primary Outcome
Title Recurrent Bacterial Vaginosis
Hide Description Recurrence by either Amsel's or Nugent's criteria. Amsel's criteria are the presence of 3 of 4 of following: 1. homogenous gray-white vaginal discharge, 2. elevated vaginal pH >4.7, 3. presence of at least 20% of vaginal epithelial cells being clue cells on wet prep microscopy, and 4. positive amine odor test on addition of 10% KOH. Nugent's criteria is based on microscopy and bacterial scoring of lactobaccilus, gardnerella, and curved gram-variable rods. A score of at least 7 is indicative of bacterial vaginosis.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone
Hide Arm/Group Description:
Receive metronidazole plus vaginal acidifying gel
Metronidazole antibiotic therapy alone
Overall Number of Participants Analyzed 29 25
Measure Type: Number
Unit of Measure: Participants
7 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metronidazole + Acidifying Gel (RepHresh), Metronidazole Alone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone
Hide Arm/Group Description Receive metronidazole plus vaginal acidifying gel Metronidazole antibiotic therapy alone
All-Cause Mortality
Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metronidazole + Acidifying Gel (RepHresh) Metronidazole Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (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 + Acidifying Gel (RepHresh) Metronidazole Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Haas, MD MS
Organization: Indiana University School of Medicine
Phone: 3176307837
Responsible Party: David M. Haas, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00545181     History of Changes
Other Study ID Numbers: 0612-58 (Study #)
First Submitted: October 15, 2007
First Posted: October 17, 2007
Results First Submitted: December 2, 2009
Results First Posted: January 7, 2010
Last Update Posted: January 12, 2010