Use of vaginal ornidazole in women of reproductive age with bacterial vaginosis: results of a multicenter observational study
Apolikhina I.A., Rakhmatulina M.R., Olina A.A., Artymuk N.V., Tarnaeva L.A., Marochko T.Yu.
Objective: To evaluate the clinical and microbiological efficacy and tolerability of a vaginal ornidazole formulation (Dazolic Lady) in women of reproductive age with bacterial vaginosis within real-world clinical practice.
Materials and methods: A prospective, multicenter, uncontrolled, observational study with a before-and-after design was conducted in real-world clinical settings. The study included 100 women aged 18–45 years with a confirmed diagnosis of bacterial vaginosis. Patients were prescribed Dazolic Lady 500 mg intravaginally once daily for 6 days. Treatment efficacy was assessed 4 weeks post-treatment via clinical examination, vaginal pH measurement, Gram-stained smear microscopy, and PCR-based analysis of the vaginal microbiota. Tolerability and treatment satisfaction were evaluated using a Likert scale.
Results: Four weeks after treatment, a significant reduction in the severity of bacterial vaginosis symptoms was observed, with only 3% of patients still reporting complaints. The mean vaginal pH level decreased significantly from 5.43 (0.39) to 4.52 (0.38) (p<0.001). The detection rate of clue cells also decreased significantly from 84% to 8% post-treatment. PCR analysis showed a statistically significant reduction in the detection rates of Gardnerella vaginalis, Fannyhessea vaginae, Mobiluncus spp., and Prevotella spp., along with a concurrent increase in the proportion of Lactobacillus spp. (p<0.05). No adverse events were reported, and 98% of patients rated treatment tolerability as good or excellent.
Conclusion: Vaginal ornidazole (Dazolic Lady) demonstrated high clinical and microbiological efficacy, an absence of adverse events, and good tolerability. These findings support its use as an effective therapeutic option for bacterial vaginosis in outpatient settings.
Authors' contributions: Apolikhina I.A., Tarnaeva L.A. – conception and design of the study, statistical analysis, collection and processing of material, drafting of the manuscript, editing of the manuscript; Rakhmatulina M.R. – conception and design of the study, collection and processing of material; Olina A.A., Artymuk N.V., Marochko T.Yu. – collection and processing of material, editing of the manuscript.
Conflicts of interest: The authors have no conflicts of interest to declare.
Funding: There was no funding for this study.
Ethical approval: The study was reviewed and approved by the Research Ethics Committee of the V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
For citation: Apolikhina I.A., Rakhmatulina M.R., Olina A.A., Artymuk N.V., Tarnaeva L.A., Marochko T.Yu. Use of vaginal ornidazole in women of reproductive age with bacterial vaginosis: results of a multicenter observational study.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2026; (2): 111-118 (in Russian)
https://dx.doi.org/10.18565/aig.2025.387
Keywords
bacterial vaginosis
vaginal microbiota
ornidazole
antibacterial therapy
Dazolic Lady
References
- Muzny C.A., Cerca N., Elnaggar J.H., Taylor C.M., Sobel J.D., Van Der Pol B. State of the art for diagnosis of bacterial vaginosis. J. Clin. Microbiol. 2023; 61(8): e0083722. https://dx.doi.org/10.1128/jcm.00837-22
- Рахматулаева М.М. Эффект полиморфизма гена интерлейкина-10 в формировании глубоких нарушений микробиоценоза влагалища при бактериальном вагинозе. Научные результаты биомедицинских исследований. 2024; 10(1): 156-70. [Rakhmatullaeva M.M. The effect of interleukin-10 gene polymorphism in the formation of deep disorders of vaginal microbiocenosis in bacterial vaginosis. Research Results in Biomedicine. 2024; 10(1): 156-70 (in Russian)]. https://dx.doi.org/10.18413/2658-6533-2024-10-1-0-10
- Воропаева Н.М., Белькова Н.Л., Немченко У.М., Григорова Е.В., Данусевич И.Н. Микроорганизмы, ассоциированные с бактериальным вагинозом: разнообразие и клинико-диагностическое значение. Acta biomedica scientifica. 2021; 6(3): 17-30. [Voropaeva N.M., Belkova N.L., Nemchenko U.M., Grigorova E.V., Danusevich I.N. Microorganisms associated with bacterial vaginosis: diversity and clinical and diagnostic significance. Acta biomedica scientifica. 2021; 6(3): 17-30 (in Russian)]. https://dx.doi.org/10.29413/ABS.2021-6.3.2
- Горбунова Е.А., Аполихина И.А. К вопросу о диагностике и лечении рефрактерных и рецидивирующих вагинозов и вагинитов в практике гинеколога. Медицинский совет. 2024; 18(4): 75-82. [Gorbunova Е.А., Apolikhina I.A. On the diagnosis and treatment of refractory and recurrent vaginosis and vaginitis in the practice of a gynecologist. Medical Council. 2024; 18(4): 75-82 (in Russian)]. https://dx.doi.org/10.21518/ms2024-165
- Leitich H., Kiss H. Asymptomatic bacterial vaginosis and intermediate flora as risk factors for adverse pregnancy outcome. Best Pract. Res. Clin. Obstet. Gynaecol. 2007; 21(3): 375-90. https://dx.doi.org/10.1016/j.bpobgyn.2006.12.005
- Atashili J., Poole C., Ndumbe P.M., Adimora A.A., Smith J.S. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008; 22(12): 1493-1501. https://dx.doi.org/10.1097/QAD.0B013E3283021A37
- Redelinghuys M.J., Geldenhuys J., Jung H., Kock M.M. Bacterial vaginosis: current diagnostic avenues and future opportunities. Front. Cell. Infect. Microbiol. 2020; 10: 354. https://dx.doi.org/10.3389/FCIMB.2020.00354
- Peebles K., Velloza J., Balkus J.E., McClelland R.S., Barnabas R.V. High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex. Transm. Dis. 2019; 46(5): 304-11. https://dx.doi.org/10.1097/OLQ.0000000000000972
- Vazquez F., Fernández-Blázquez A., García B. Vaginosis. Vaginal microbiota. Enferm. Infecc. Microbiol. Clin. (Engl. Ed). 2019; 37(9): 592-601. English, Spanish. https://dx.doi.org/10.1016/j.eimc.2018.11.009
- Миханошина Н.В., Припутневич Т.В., Григорян И.Э. Вагиниты и вагиноз: подходы к диагностике и лечению в свете действующих клинических рекомендаций. Акушерство и гинекология. 2022; 11: 172-8. [Mikhanoshina N.V., Priputnevich T.V., Grigorian I.E. Vaginitis and vaginosis: diagnostic and treatment approaches in the light of the current clinical practice guidelines. Obstetrics and Gynecology. 2022; (11): 172-8 (in Russian)]. https://dx.doi.org/10.18565/aig.2022.11.172-178
- Ozyazici M., Gökçe E., Hizarcioglu S.Y., Taner M.S., Köseoglu K., Ertan G. Dissolution and vaginal absorption characteristics of metronidazole and ornidazole. Pharmazie. 2006; 61(10): 855-61.
- Lindner J.G., Plantema F.H., De Vos N.M., Hoogkamp-Korstanje A.A. Reaction of the vaginal flora to ornidazol in patients with cervicitis. Chemotherapy. 1979; 25(4): 243-8. https://dx.doi.org/10.1159/000237846
- Saraçoǧlu F., Göl K., Şahin Ï., Türkkani B., Atalay C., Öztopçu C. Treatment of bacterial vaginosis with oral or vaginal ornidazole, secnidazole and metronidazole. Int. J. Gynecol. Obstet. 1998; 62(1): 59-61. https://dx.doi.org/10.1016/S0020-7292(98)00029-0
- Thulkar J., Kriplani A., Agarwal N. A comparative study of oral single dose of metronidazole, tinidazole, secnidazole and ornidazole in bacterial vaginosis. Indian. J. Pharmacol. 2012; 44(2): 243-5. https://dx.doi.org/10.4103/0253-7613.93859
- Рахматулина М.Р. Опыт применения 5-нитроимидазолов в терапии больных с бактериальным вагинозом. Российский вестник акушера-гинеколога. 2015; 15(2): 92-7. [Rakhmatulina M.R. Experience with 5-nitroimidazoles in the therapy of bacterial vaginosis. Russian Bulletin of Obstetrician-Gynecologist. 2015; 15(2): 92-7 (in Russian)]. https://dx.doi.org/10.17116/rosakush201515292-97
- Fan Y., Gu Y., Xian Y., Li Q., He Y., Chen K. et al. Efficacy and safety of different drugs for the treatment of bacterial vaginosis: a systematic review and network meta-analysis. Front. Cell. Infect. Microbiol. 2024; 14: 1402346. https://dx.doi.org/10.3389/fcimb.2024.1402346
- Олина А.А., Савичева А.М., Будиловская О.В., Метелева Т.А. Конкурентные преимущества орнидазола в лечении бактериального вагиноза. Вопросы гинекологии, акушерства и перинатологии. 2025; 24(4): 166-73. [Olina A.A., Savicheva A.M., Budilovskaya O.V., Meteleva T.A. Competitive advantages of ornidazole in the treatment of bacterial vaginosis. Gynecology, Obstetrics and Perinatology. 2025; 24(4): 166-73 (in Russian)]. https://dx.doi.org/10.20953/1726-1678-2025-4-166-173
- Swidsinski S., Moll W.M., Swidsinski A. Bacterial vaginosis – vaginal polymicrobial biofilms and dysbiosis. Dtsch. Arztebl. Int. 2023; 120(20): 347-54. https://dx.doi.org/10.3238/ARZTEBL.M2023.0090
Received 29.12.2025
Accepted 02.02.2026
About the Authors
Inna A. Apolikhina, Dr. Med. Sci., Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4; Professor at the Department of Obstetrics, Gynecology, Perinatology and Reproductology of the Institute of Vocational Education, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), apolikhina@inbox.ru, https://orcid.org/0000-0002-4581-6295Margarita R. Rakhmatulina, Dr. Med. Sci., Professor, Deputy Director for Organizational and Analytical Work, State Research Center of Dermatovenereology and Cosmetology, Ministry of Health of Russia, 107076, Russia, Moscow, Korolenko str., 3, bldg. 6, rahmatulina@cnikvi.ru, https://orcid.org/0000-0003-3039-7769
Anna A. Olina, Dr. Med. Sci., Professor, Deputy Director for Development, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, 199034, Russia,
St. Petersburg, Mendeleevskaya Line, 3; Professor at the Department of Obstetrics and Gynecology, Academician E.A. Wagner Perm State Medical University, Ministry of Health of Russia; Professor at the Department of Obstetrics and Gynecology named after S.N. Davydov, I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia, olina29@mail.ru, https://orcid.org/0000-0001-9101-7569
Natalia V. Artymuk, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology named after Prof. G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of Russia, 650056, Russia, Kemerovo, Voroshilova str., 22a, +7(3842)73-48-56, artymuk@gmail.com, https://orcid.org/0000-0001-7014-6492
Liana A. Tarnaeva, Obstetrician-Gynecologist, PhD Student, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, +7(915)112-77-52, li.tarnaeva@ya.ru, https://orcid.org/0009-0006-7500-7516
Tatiana Yu. Marochko, PhD, Associate Professor at the Department of Obstetrics and Gynecology named after Prof. G.A. Ushakova, Kemerovo State Medical University, Ministry of Health of Russia, 650056, Russia, Kemerovo, Voroshilova str., 22a, +7(3842)73-48-56, marochko.2006.68@mail.ru, https://orcid.org/0000-0001-5641-5246
Similar Articles
