Professional paper
Effectiveness and Pharmacokinetic evaluation of Geonistin® (Oxytetracyline and Nystatin) Vaginal Tablets for Unspecific and Mixed Vulvovaginal Infections (GENIE Study)
Višnja Škerk
; Department for Urogenital infections, Dr. Fran Mihaljević University Hospital for Infectious Diseases, Zagreb, Croatia
Adela Kolumbić Lakoš
; PLIVA Croatia LTD, Zagreb, Croatia
Maja Gašparić
; Teva Pharmaceuticals Europe BV, Amsterdam, Netherlands
Mirjana Matrapazovski Kukuruzović
; PLIVA Croatia LTD, Zagreb, Croatia
Ivana Magdić Blažević
; PLIVA Croatia LTD, Zagreb, Croatia
Abstract
The GENIE study was performed to evaluate the effectiveness and systemic exposure to oxytetracycline in local treatment of unspecific and mixed vulvovaginal infections characterized by vaginal discharge with Geonistin® vaginal tablets (100 mg oxytetracycline and 100 000 IU nystatin). The total number of subjects enrolled was 189. The treatment had beneficial effects in 100% of the study population. According to the Nugent score, the treatment had a positive effect in 89.2% of participants. The microbiological cure rate was 78.8%. Oxytetracycline concentration levels were from 13.3 to 32.2 ng/mL in 11 out of 15 subjects, and in four subjects the levels were below 10 ng/mL. Geonistin® had a beneficial effect on the unspecific and mixed vulvovaginal infections characterized by vaginal discharge in all efficacy and safety outcomes. Microbiological and the Nugent score efficacy measures confirmed clinical effectiveness. Beneficial efficacy results were achieved with only a few non-serious adverse events.
Keywords
oxytetracycline; nystatin; vaginal discharge; vaginitis; vulvovaginitis; pharmacokinetics
Hrčak ID:
290094
URI
Publication date:
20.11.2019.
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