This is an open-label, three center, randomized, multiple-dose, two-group, parallel treatment study. An attempt will be made to match the patients in the two groups by age. One treatment group will consist of 24 non-pregnant female patients diagnosed with bacterial vainosis and the other treatment group will consist of 24 patients in their second to third trimester of pregnancy requiring treatment for bacterial vaginosis. The primary objective of this study is to compare the steady-state pharmacokinetics of metronidazole, after a daily oral dose of Flagyl ER (metronidazole extended release tablets, 750 mg), administered for 7 days between non-pregnant female patients and patients in their second to third trimester of pregnancy requiring treatment for bacterial vaginosis. The secondary objective of this study is to compare the safety and effectiveness of Flagyl ER in non-pregnant and pregnant patients requiring treatment for bacterial vaginsosi.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000048-40
Application #
6441691
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Northwestern University at Chicago
Department
Type
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
Sherenian, Michael G; Singh, Anne M; Arguelles, Lester et al. (2018) Association of food allergy and decreased lung function in children and young adults with asthma. Ann Allergy Asthma Immunol 121:588-593.e1
Baron, Kelly Glazer; Reid, Kathryn J; Malkani, Roneil G et al. (2017) Sleep Variability Among Older Adults With Insomnia: Associations With Sleep Quality and Cardiometabolic Disease Risk. Behav Sleep Med 15:144-157
Gupta, Ruchi S; Walkner, Madeline M; Greenhawt, Matthew et al. (2016) Food Allergy Sensitization and Presentation in Siblings of Food Allergic Children. J Allergy Clin Immunol Pract 4:956-62
Raghanti, Mary Ann; Edler, Melissa K; Stephenson, Alexa R et al. (2016) Human-specific increase of dopaminergic innervation in a striatal region associated with speech and language: A comparative analysis of the primate basal ganglia. J Comp Neurol 524:2117-29
Slama, Laurence; Jacobson, Lisa P; Li, Xiuhong et al. (2016) Longitudinal Changes Over 10 Years in Free Testosterone Among HIV-Infected and HIV-Uninfected Men. J Acquir Immune Defic Syndr 71:57-64
Makhija, Melanie M; Robison, Rachel G; Caruso, Deanna et al. (2016) Patterns of allergen sensitization and self-reported allergic disease in parents of food allergic children. Ann Allergy Asthma Immunol 117:382-386.e1
Ye, Wen; Rosenthal, Philip; Magee, John C et al. (2015) Factors Determining ?-Bilirubin Levels in Infants With Biliary Atresia. J Pediatr Gastroenterol Nutr 60:659-63
Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23
Lertratanakul, Apinya; Wu, Peggy; Dyer, Alan R et al. (2014) Risk factors in the progression of subclinical atherosclerosis in women with systemic lupus erythematosus. Arthritis Care Res (Hoboken) 66:1177-85
Nodzenski, Michael; Muehlbauer, Michael J; Bain, James R et al. (2014) Metabomxtr: an R package for mixture-model analysis of non-targeted metabolomics data. Bioinformatics 30:3287-8

Showing the most recent 10 out of 189 publications