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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Metronidazole + Acidifying Gel (RepHresh) Receive metronidazole plus vaginal acidifying gel
Metronidazole Alone Metronidazole antibiotic therapy alone

Participant Flow:   Overall Study
    Metronidazole + Acidifying Gel (RepHresh)   Metronidazole Alone
STARTED   29   25 
COMPLETED   29   25 
NOT COMPLETED   0   0 



  Baseline Characteristics

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 + Acidifying Gel (RepHresh) Receive metronidazole plus vaginal acidifying gel
Metronidazole Alone Metronidazole antibiotic therapy alone
Total Total of all reporting groups

Baseline Measures
   Metronidazole + Acidifying Gel (RepHresh)   Metronidazole Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   25   54 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   29   25   54 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.8  (5.8)   32.4  (6.9)   31.0  (6.4) 
Gender 
[Units: Participants]
     
Female   29   25   54 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   29   25   54 


  Outcome Measures

1.  Primary:   Recurrent Bacterial Vaginosis   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

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
e-mail: dahaas@iupui.edu



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