The Efficacy and Safety of Gynomax (R) XL Vaginal Ovule in the Treatment of Common Vaginal Infections: A Single-Arm Clinical Trial, Gyno-Turk

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dc.authoridDilbaz, Berna/0000-0003-1137-8650
dc.authorscopusid7003616604
dc.authorscopusid55561015200
dc.authorscopusid16164265800
dc.authorscopusid6603405713
dc.authorscopusid57212960094
dc.authorscopusid6602585294
dc.authorscopusid6507459615
dc.contributor.authorTavmergen, Erol
dc.contributor.authorAcet, Ferruh
dc.contributor.authorTaner, Cuneyt Eftal
dc.contributor.authorDurmusoglu, Fatih
dc.contributor.authorUstun, Yaprak
dc.contributor.authorDilbaz, Berna
dc.contributor.authorCilli, Fatma Feriha
dc.date.accessioned2023-01-12T20:18:51Z
dc.date.available2023-01-12T20:18:51Z
dc.date.issued2021
dc.departmentN/A/Departmenten_US
dc.description.abstractObjective: The objective of this study was to evaluate the efficacy, safety, and tolerability of Gynomax (R) XL vaginal ovule in the treatment of bacterial vaginosis ( BV), candidal vulvovaginitis (CVV), trichomonal vaginitis (TV), and mixed vaginal infections (MVI). Material and Methods: A total of 98 women diagnosed clinically with BV, CVV, TV, or MVI have completed this study. Patients were given Gynomax (R) XL for 3 consecutive days, and approximately 10 (+/-5) days after the treatment, a follow-up visit was conducted. In addition to the clinical examinations, vaginal swab samples were collected in both visits for microbiological tests. Results: Based on the clinical diagnosis of the investigators, most of the patients had MVIs (54.1%), followed by BV (24.5%) and CVV (20.4%) at the baseline visit. One (1.0%) patient was diagnosed as having TV. According to the microbiologic examination results, 44 (44.9%) patients had BV, 20 (20.4%) had CVV, and 13 (13.3%) had MVIs. According to the clinical findings, overall complete recovery (CR) was observed in 76.5% of the patients and according to the microbiologic findings, overall CR was observed in 85.7% of the patients. Microbiologic results evaluated by each diagnostic criterion showed that CR was detected in 93.2%, 85.0%, and 61.5% of the patients with BV, CVV, and MVIs, respectively. There were no serious or non-serious adverse events leading to patient withdrawal or treatment discontinuation during this study. Conclusion: Gynomax (R) XL vaginal ovules administered once daily for three consecutive days provide effective and safe treatment in patients with BV, CVV, and MVIs.en_US
dc.description.sponsorshipExeltis Ilac, Istanbul, Turkey [MON564.13.1]en_US
dc.description.sponsorshipExeltis Ilac, Istanbul, Turkey, provided full financial sponsorship for this study (project code: MON564.13.1) including study medications, patient consultation fees, laboratory payments and investigator payments.en_US
dc.identifier.doi10.5336/jcog.2021-85924
dc.identifier.endpage128en_US
dc.identifier.issn2619-9467
dc.identifier.issn2619-9467en_US
dc.identifier.issue4en_US
dc.identifier.scopus2-s2.0-85124612685en_US
dc.identifier.scopusqualityQ4en_US
dc.identifier.startpage120en_US
dc.identifier.urihttps://doi.org/10.5336/jcog.2021-85924
dc.identifier.urihttps://hdl.handle.net/11454/78946
dc.identifier.volume31en_US
dc.identifier.wosWOS:000871242000003en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherTurkiye Kliniklerien_US
dc.relation.ispartofJournal Of Clinical Obstetrics And Gynecologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectEfficacyen_US
dc.subjectGynomaxen_US
dc.subjectlidocaineen_US
dc.subjectsafetyen_US
dc.subjecttinidazoleen_US
dc.subjecttioconazoleen_US
dc.subjectTrichomonas-Vaginalisen_US
dc.subjectBacterial Vaginosisen_US
dc.subjectVaginitis Diagnosisen_US
dc.subjectTinidazoleen_US
dc.subjectMetronidazoleen_US
dc.subjectTioconazoleen_US
dc.titleThe Efficacy and Safety of Gynomax (R) XL Vaginal Ovule in the Treatment of Common Vaginal Infections: A Single-Arm Clinical Trial, Gyno-Turken_US
dc.typeArticleen_US

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