Results of a multicenter prospective observational study of the efficacy of a combination medication containing tioconazole, tinidazole and lidocaine, in the form of vaginal suppositories, in the treatment of vulvovaginal infections in routine clinical practice (Angara study)
Apolikhina I.A., Savicheva A.M., Dubrovina S.O., Kazakova S.N., Loginov A.B., Mingareeva K.N., Neufeld I.V., Saveljeva I.V., Sokolova T.M., Tapilskaya N.I., Boris D.A.
Objective. To assess the prevalence of various vulvovaginal infections (VVIs) and the clinical efficacy and safety of a medicinal product containing tioconazole, tinidazole and lidocaine, in the form of vaginal suppositories (Gynomax Plus), in women with VVIs in routine clinical practice.
Materials and methods. The study included 140 women aged 18–49 who were diagnosed with VVIs and were prescribed a three-day course of treatment with Gynomax Plus. The study assessed the rate of clinical treatment success and the rate of eradication of VVI pathogens, the rate of symptom disappearance, changes in the pH of vaginal discharge, as well as the rate of success in treating concomitant cervicitis, ease of use and safety.
Results. Among 140 patients included in the study, mixed VVIs were the most common (60.71%); candidal vulvovaginitis (27.14%), bacterial vaginosis (11.43%) and aerobic vaginitis (0.71%) were diagnosed less frequently. Clinical success was noted in 97.1% of patients at visit 2 (day 10–14) and persisted in 89.6% at visit 3 (day 28–30). The average time taken for abnormal vaginal discharge, a burning sensation and itching to disappear was 2.43–2.77 days; dyspareunia resolved more quickly (after 1.74 days). Furthermore, 85% of patients reported an improvement within the first day of using the medication. High microbiological effectiveness was observed: pathogen eradication was 100% for aerobic bacteria and 75-100% for most anaerobic microorganisms (including 75% for Gardnerella vaginalis and 100% for Atopobium vaginae), 100% for Mycoplasma hominis, 68.0% for Candida spp. and 50.0% for Ureaplasma spp. The treatment of concomitant cervicitis was successful in 92.9% of cases. The mean pH decreased from 5.42±0.89 to 4.37±0.60. Adverse events were reported in 4.3% of patients (6/138); these were mild and were not associated with the treatment.
Conclusion. In routine clinical practice, mixed vaginal infections are the most common. The medicinal product «Gynomax Plus» has demonstrated high clinical efficacy, significant eradication of VVI pathogens, high efficacy in the treatment of concomitant cervicitis, and a favorable safety profile.
Authors’ contributions. Apolikhina I.A., Savicheva A.M., Boris D.A., Dubrovina S.O. – developing the concept and design of the study, consulting on the organization of the study and methods of patient assessment, analysis of the data obtained, writing the text of the article; Kazakova S.N., Loginov A.B., Mingareeva K.N., Neufeld I.V., Saveljeva I.V., Sokolova T.M., Tapilskaya N.I. – collecting the clinical material, editing and approval of the final version of the manuscript.
Conflicts of interest. Authors declare lack of the possible conflicts of interests.
Funding. The research and preparation of the article were funded by Altseya LLC. The sponsor had no influence on the analysis of the data or interpretation of the results.
Acknowledgements. The authors would like to thank the researchers M.Yu. Korshunov, M.N. Ulyanets, A.V. Tigieva, N.A. Shulgina, T.P. Zefirova for collecting the clinical data. The authors express their gratitude to the staff of Axon Clinical Trail Lab LLC, namely D.V. Kryuchkov, O.I. Latysheva, and F.A. Sigalov, for organizing the study in accordance with the principles of Good Clinical Practice. Gratitude for the technical writing of the research documents is expressed to Yu.V. Kamanina, E.E. Marochkina. Gratitude for the project management of the study is expressed to K.A. Sokolov and O.V. Zinovieva, staff members of Alcea LLC. Gratitude for ensuring proper reporting of safety data is expressed to A.I. Glushkova, registration manager of Alcea LLC.
Ethical Approval. The study was approved by the local ethics committees/independent ethics committees of all 11 research centers prior to the inclusion of the patients.
Generative Artificial Intelligence. Artificial intelligence technologies were not used in the preparation of this article.
Patient Consent for Publication. All patients signed an informed consent to participate in the study and have their data published.
Authors' Data Sharing Statement. The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Apolikhina I.A., Savicheva A.M., Dubrovina S.O., Kazakova S.N., Loginov A.B., Mingareeva K.N., Neufeld I.V., Saveljeva I.V., Sokolova T.M., Tapilskaya N.I., Boris D.A. Results of a multicenter prospective observational study of the efficacy of a combination medication containing tioconazole, tinidazole and lidocaine, in the form of vaginal suppositories, in the treatment of vulvovaginal infections in routine clinical practice (Angara study).
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2026; (6): 197-208 (in Russian)
https://dx.doi.org/10.18565/aig.2026.182
Keywords
vulvovaginal infections
bacterial vaginosis
candidiasis vulvovaginitis
mixed vulvovaginal infections
tioconazole
tinidazole
lidocaine
Gynomax Plus
eradication of pathogens
cervicitis
References
- Workowski K.A., Bachmann L.H., Chan P.A., Johnston C.M., Muzny C.A., Park I. et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm. Rep. 2021; 70(4): 1-187. https://dx.doi.org/10.15585/mmwr.rr7004a1
- Sherrard J., Wilson J., Donders G., Mendling W., Jensen J.S. 2018 European (IUSTI/WHO) International Union against sexually transmitted infections (IUSTI) World Health Organisation (WHO) guideline on the management of vaginal discharge. Int. J. STD AIDS. 2018; 29(13): 1258-72. https://dx.doi.org/10.1177/0956462418785451
- Denning D.W., Kneale M., Sobel J.D., Rautemaa-Richardson R. Global burden of recurrent vulvovaginal candidiasis: a systematic review. Lancet Infect. Dis. 2018; 18(11): e339-47. https://dx.doi.org/10.1016/s1473-3099(18)30103-8
- Muzny C.A., Schwebke J.R. Pathogenesis of bacterial vaginosis: discussion of current hypotheses. J. Infect. Dis. 2016; 214(Suppl 1): S1-5. https://dx.doi.org/10.1093/infdis/jiw121
- Peddakolmi S., Shiraskar O., Bhor V.M. Vaginal dysbiosis-associated infections: current and emerging treatment strategies. J. Reprod. Healthc Med. 2025; 6: 23. https://dx.doi.org/10.25259/jrhm_32_2025
- Brown H., Drexler M. Improving the diagnosis of vulvovaginitis: perspectives to align practice, guidelines, and awareness. Popul. Health Manag. 2020; 23(S1): S3-12. https://dx.doi.org/10.1089/pop.2020.0265
- Министерство здравоохранения Российской Федерации. Клинические рекомендации. Воспалительные болезни шейки матки, влагалища и вульвы. 2025. Доступно по: https://cr.minzdrav.gov.ru/view-cr/989_1 [Ministry of Health of the Russian Federation. Clinical guidelines. Inflammatory diseases of the cervix, vagina, and vulva. 2025 (in Russian). Available at: https://cr.minzdrav.gov.ru/view-cr/989_1].
- Радзинский В.Е., Савичева А.М., ред. Биоценоз влагалища. Норма. Нарушения. Восстановление. М.: StatusPraesens; 2026. 360 с. https://dx.doi.org/10.29039/978-5-907218-72-7 [Radzinsky V.E., Savicheva A.M., eds. Vaginal biocenosis. Standard. Violations. Recovery. Moscow: StatusPraesens; 2026. 360 p. (in Russian). https://dx.doi.org/10.29039/978-5-907218-72-7].
- Vieira-Baptista P., Stockdale C.K., Sobel J., eds. International Society for the Study of Vulvovaginal Disease recommendations for the diagnosis and treatment of vaginitis. Lisbon: Admedic; 2023. 195 p. https://dx.doi.org/10.59153/adm.rdtv.001
- Общая характеристика лекарственного препарата «Нео-Пенотран Форте». ЛП-№(010022)-(РГ-RU) от 30.04.2025. Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC [General characteristics of the drug Neo-Penotran Forte. LP-No.(010022)-(RG-RU) dated 30.04.2025. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russian)].
- Общая характеристика лекарственного препарата «Тержинан». ЛП-№(001203)-(РГ-RU) от 13.09.2022. Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC [General characteristics of the drug Terzhinan. LP-No.(001203)-(RG-RU) dated 13.09.2022. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russian)].
- Общая характеристика лекарственного препарата «Эльжина». ЛП-№(003899)-(РГ-RU) от 04.12.2023. Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC [General characteristics of the drug Elzhina. LP-No.(003899)-(RG-RU) dated 04.12.2023. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russian)].
- Общая характеристика лекарственного препарата «Полижинакс». ЛП-№(007371)-(РГ-RU) от 24.10.2024. Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC [General characteristics of the drug Polygynax. LP-No.(007371)-(RG-RU) dated 24.10.2024. Available at: https://lk.regmed.ru/Register/EAEU_SmPC (in Russian)].
- Erfaninejad M., Salahshouri A., Amirrajab N. Barriers and facilitators of adherence to treatment among women with vulvovaginal candidiasis: a qualitative study. Eur. J. Med. Res. 2022; 27(1): 303. https://dx.doi.org/10.1186/s40001-022-00938-y
- Regidor P.A., Sailer M. Open prospective study to evaluate the efficacy of a new vaginal pessary containing 300 mg tinidazole, 200 mg tioconazole and 100 mg lidocaine with a 3-day regime (GynomaxXL®) in the treatment of vaginal infections due to bacterial vaginosis, candidiasis and mixed infections. Biomed. J. Sci. Techn. Res. 2019; 12(5): 1-11. https://dx.doi.org/10.26717/BJSTR.2019.12.002327
- Соколова Т.М., Маринкин И.О., Макаров К.Ю., Кулешов В.М., Пилецкая У.В. Эмпирическая терапия вульвовагинитов у женщин репродуктивного возраста. Эффективная фармакотерапия. 2021; 17(9): 16-20. https://dx.doi.org/10.33978/2307-3586-2021-17-9-16-20 [Sokolova T.M., Marinkin I.O., Makarov K.Yu., Kuleshov V.M., Pileckaya U.V. Embryonic therapy of vulvovaginitis in women of reproductive age. Effective pharmacotherapy. 2021; 17(9): 16-20 (in Russian). https://dx.doi.org/10.33978/2307-3586-2021-17-9-16-20].
- Соколова Т.М., Макаров К.Ю., Кулешов В.М., Киселева Т.В. Смешанный вагинит в современных условиях: особенности течения и терапии. Вопросы гинекологии, акушерства и перинатологии. 2024; 23(5): 89-96. https://dx.doi.org/10.20953/1726-1678-2024-5-89-96 [Sokolova T.M., Makarov K.Yu., Kuleshov V.M., Kiseleva T.V. Mixed vaginitis in current conditions: characteristics of clinical course and therapy. Gynecology, Obstetrics and Perinatology. 2024; 23(5): 89-96 (in Russian). https://dx.doi.org/10.20953/1726-1678-2024-5-89-96].
- Савельева И.В., Бухарова Е.А., Галянская Е.Г., Носова Н.В., Давыдов П.В. Возможности комбинированной терапии больных смешанным вагинитом в репродуктивном возрасте. Акушерство, гинекология и репродукция. 2024; 18(6): 800-8. https://dx.doi.org/10.17749/2313-7347/ob.gyn.rep.2024.572 [Savelieva I.V., Bukharova E.A., Galyanskaya E.G., Nosova N.V., Davydov P.V. Opportunities of combination therapy in reproductive age patients with bacterial vaginosis combined with vulvovaginal candidiasis. Obstetrics, Gynecology and Reproduction. 2024; 18(6): 800-8 (in Russian). https://dx.doi.org/10.17749/2313-7347/ob.gyn.rep.2024.572].
- Торшин И.Ю., Аполихина И.А., Баранов И.И., Тапильская Н.И., Савичева А.М., Громова О.А. Эффективность и безопасность комбинации тинидазола и тиоконазола в лечении вагинальных инфекций. Акушерство и гинекология. 2020; 4: 214-22. https://dx.doi.org/10.18565/aig.2020.4.214-222 [Torshin I.Yu., Apolikhina I.A., Baranov I.I., Tapilskaya N.I., Savicheva A.M., Gromova O.A. Efficacy and safety of the combination of tinidazole and thiokonazole in the treatment of vaginal infections. Obstetrics and Gynecology. 2020; (4): 214-22 (in Russian). https://dx.doi.org/10.18565/aig.2020.4.214-222].
- Ших Е.В., Лазарева Н.Б., Ших Н.В. Сравнительная клинико-фармакологическая характеристика антимикробных препаратов для лечения вульвовагинальных инфекций. Вопросы гинекологии, акушерства и перинатологии. 2025; 24(6): 149-58. https://dx.doi.org/10.20953/1726-1678-2025-6-149-158 [Shikh E.V., Lazareva N.B., Shikh N.V. Comparative clinical and pharmacological characteristics of antimicrobials for the treatment of vulvovaginal infections. Gynecology, Obstetrics and Perinatology. 2025; 24(6): 149-58 (in Russian). https://dx.doi.org/10.20953/1726-1678-2025-6-149-158].
Received 09.06.2026
Accepted 19.06.2026
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. Oparin str., 4; Professor, Department of Obstetrics, Gynecology, Perinatology and Reproductology, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), i_apolikhina@oparina4.ru,https://orcid.org/0000-0002-4581-6295
Alevtina M. Savicheva, Dr. Med. Sci., Professor, Honored Scientist of the Russian Federation, Head of the Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, 3 Mendeleyevskaya Line, 199034, St. Petersburg, Russia, savitcheva@mail.ru, https://orcid.org/0000-0003-3870-5930
Svetlana O. Dubrovina, Professor, Dr. Med. Sci., Chief Researcher, Obstetrics and Pediatrics Research Institute, RostSMU, Ministry of Health of Russia; Professor at the Department of Obstetrics and Gynecology No. 1, RostSMU, Ministry of Health of Russia, 344012, Russia, Rostov-on-Don, Mechnikov str., 43, s.dubrovina@gmail.com
Svetlana N. Kazakova, PhD, obstetrician-gynecologist, Atlas Multidisciplinary Medical Center, 121352, Russia, Moscow, Kremenchugskaya str., 3, s-juice@mail.ru,
https://orcid.org/0000-0003-1273-213x
Alexander B. Loginov, PhD, Associate Professor, Department of Obstetrics, Gynecology and Neonatology, Pavlov First St. Petersburg State Medical University, Ministry of Health of Russia, 197022, Russia, St. Petersburg, Leo Tolstoy str., 6-8; deputy. Chief Physician, Maternity Hospital No. 6 named after Prof. V.F. Snegirev, St. Petersburg.
Karina N. Mingareeva, PhD, Associate Professor at the Department of Obstetrics and Gynecology No. 2, Bashkir State Medical University, Ministry of Health of Russia, 450008, Russia, Republic of Bashkortostan, Ufa, Lenin str., 3, mkn1805@mail.ru, https://orcid.org/0000-0001-9125-2614
Irina V. Neufeld, PhD, Associate Professor, Head of the Educational Part of the Department of Obstetrics and Gynecology, Saratov State Medical University named
after V.I. Razumovsky, Ministry of Health of Russia, 410012, Russia, Saratov, B. Kazachja str., 112.
Irina V. Saveljeva, Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 1, Omsk State Medical University, Ministry of Health of Russia, 644099, Russia, Omsk, Lenin str., 12; Chief Freelance Specialist in Obstetrics and Gynecology of the Ministry of Health of the Omsk region, saveljeva_iv_omsk@mail.ru, https://orcid.org/0000-0001-9342-7342
Tatyana M. Sokolova, Dr. Med. Sci., Professor, Department of Obstetrics and Gynecology, Novosibirsk State Medical University, Ministry of Health of Russia, 630091, Russia, Novosibirsk, Krasnyi Ave., 52, tatyana3965@mail.ru, https://orcid.org/0000-0003-3435-3536
Natalia I. Tapilskaya, Dr. Med. Sci., Professor, Head of the Department of Gynecology and Endocrinology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, 199034, Russia, St. Petersburg, Mendeleyevskaya line, 3, tapnatalia@mail.ru, https://orcid.org/0000-0001-5309-0087
Daiana A. Boris, PhD, obstetrician-gynecologist, doctor of ultrasound diagnostics, Senior Researcher at 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. Oparin str., 4, dayana_boris@mail.ru, https://orcid.org/0000-0002-0387-4040
Similar Articles
