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Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01230814
First received: October 28, 2010
Last updated: September 26, 2014
Last verified: September 2014
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Bacterial Vaginosis
Candidiasis
Trichomoniasis
Interventions: Drug: Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
Drug: Placebo

  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
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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
Arm 1: Metronidazole Plus Miconazole Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
Arm 2: Placebo Placebo suppositories nightly for five consecutive nights each month.

Participant Flow:   Overall Study
    Arm 1: Metronidazole Plus Miconazole   Arm 2: Placebo
STARTED   118   116 
COMPLETED   105   112 
NOT COMPLETED   13   4 
Lost to Follow-up                11                3 
Discontinued (not due to adverse event)                2                1 



  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.
All randomized participants.

Reporting Groups
  Description
Arm 1: Metronidazole Plus Miconazole Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
Arm 2: Placebo Placebo suppositories nightly for five consecutive nights each month.
Total Total of all reporting groups

Baseline Measures
   Arm 1: Metronidazole Plus Miconazole   Arm 2: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 118   116   234 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 29 
 (24 to 34) 
 29 
 (23 to 35) 
 29 
 (24 to 34) 
Age 
[Units: Participants]
     
<=18 years   1   1   2 
Between 18 and 65 years   117   115   232 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   118   116   234 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   118   111   229 
White   0   4   4 
More than one race   0   1   1 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   118   115   233 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   29   29   58 
Kenya   89   87   176 


  Outcome Measures
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1.  Primary:   Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Vulvovaginal Candidiasis (VVC).   [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]

2.  Primary:   Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing Bacterial Vaginosis (BV).   [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]

3.  Secondary:   Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Placebo for Preventing Any Vaginal Infection (a Combined Endpoint Including BV, VVC, and Trichomonas Vaginalis Infection).   [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]

4.  Secondary:   Efficacy of Monthly Periodic Presumptive Treatment (PPT) Using Metronidazole With Miconazole Intravaginal Suppositories Versus Matching Placebo Nightly for Five Nights Each Month for Preventing BV by Clinical Criteria (Amsel’s Criteria).   [ Time Frame: Months 2, 4, 6, 8, 10, and 12. ]


  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
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  More Information
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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: Shelly Lensing, MS
Organization: University of Arkansas for Medical Sciences
phone: 501-686-8203
e-mail: sylensing@uams.edu



Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01230814     History of Changes
Other Study ID Numbers: 09-0070
DMID STI CTG 09-0070 PVI
Study First Received: October 28, 2010
Results First Received: August 14, 2014
Last Updated: September 26, 2014
Health Authority: Kenya: Ministry of Health
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board