Phase III Study to Evaluate the Efficacy and Safety of Two Novel Fixed-Dose Vaginal Ovule Formulations in the Treatment of Various Vaginal Infections: One-Shot Study Running Title: Phase III study of two novel vaginal ovules
Authors:   Department of IVF Research and Training Center, Ege University Faculty of Medicine, Izmir, Türkiye, Tavmergen Erol , Acet Ferruh ,   Department of IVF Research and Training Center, Ege University Faculty of Medicine, Izmir, Türkiye, Bahat Pınar Yalçın ,   Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Research and Training Hospital, Istanbul, Türkiye, Karadağ Burak ,   Department of Obstetrics and Gynecology, Antalya Research and Training Hospital, Antalya, Türkiye, Yaşar Levent ,   Department of Obstetrics and Gynecology, Bakırköy Dr. Sadi Konuk Training and Research Hospital, University of Health Sciences, Istanbul, Türkiye, Kale Ahmet ,   Department of Obstetrics and Gynecology, Kartal Dr. Lutfi Kırdar Research and Training Hospital, University of Health Sciences, Istanbul, Türkiye, Aydoğmuş Serpil ,   Department of Obstetrics and Gynecology, Ataturk Training and Research Hospital, Katip Celebi University Faculty of Medicine, Izmir, Türkiye, Dilbaz Berna ,   Department of Obstetrics and Gynecology, Etlik Zübeyde Hanim Women's Health Training and Research Hospital, University of Health Sciences, Ankara, Türkiye, Taner Cüneyt Eftal ,   Department of Obstetrics and Gynecology, Medicana International Hospital, Izmir, Türkiye, Durmuşoğlu Fatih ,   Department of Obstetrics and Gynecology, Medipol University School of Medicine, Istanbul, Türkiye, Çilli Feriha ,   Department of Medical Microbiology, Ege University Faculty of Medicine, Izmir, Türkiye
Published: June 2024

Objective: This study aimed to evaluate the efficacy and safety of two novel formulations: one containing fenticonazole nitrate 600 mg + tinidazole 1000 mg + lidocaine 100 mg (Formulation A) and the other with fenticonazole nitrate 600 mg + tinidazole 2000 mg + lidocaine 100 mg (Formulation B) in the treatment of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonas vaginitis (TV), and mixed vaginal infections (MVIs) in comparison to comparator medication (Gynomax® XL). Materials and methods: This phase III study enrolled 562 adult, pre-menopausal patients with BV, VVC, TV, or MVIs. Of these, 544 received the study medication (included in the safety analysis), and 440 completed the study (included in the efficacy analysis). Patients were randomized into Formulation A, Formulation B, or comparator medication arms. Follow-up visits were conducted two weeks post-treatment, with clinical and microbiological evaluations. Results: Initial clinical diagnoses indicated BV (62.0%), VVC (19.8%), MVIs (15.5%), and TV (2.7%). High clinical recovery rates were observed with Formulation A (96.7% of BV, 81.8% of VVC, and 96.3% of MVIs), Formulation B (97.7% of BV, 88.2% of VVC, 90.9% of MVIs), and comparator medication (98.9% of BV, 90.3% of VVC, 100.0% of MVIs). None of the patients discontinued medications due to an adverse event or intolerability. Conclusion: All formulations are considered as safe, well-tolerated, and highly effective for treating BV, VVC, and MVIs. Formulation A or B may be particularly advantageous due to anticipated greater patient compliance with their single-dose administration.