The Efficacy and Safety of Gynomax® XL Vaginal Ovule in the Treatment of Common Vaginal Infections: A Single-Arm Clinical Trial, Gyno-Türk

Abstract

The objective of this study was to evaluate the efficacy, safety, and tolerability of Gynomax ® 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 ® 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 ® XL vaginal ovules administered once daily for three consecutive days provide effective and safe treatment in patients with BV, CVV, and MVIs.

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

“…While our study results generally align with these findings, our tenth-day cure rate was slightly higher (95.5% vs 80.6%) than what was reported. Clinical recovery rates in Gyno-Türk study [13], sharing a similar study design but being a single-arm study, were comparable to our study (95.5% vs 96.9%).…”

“…AE distribution was similar across all three treatment arms. In comparison with the Gyno-Türk study, where 14.6% of the patients experienced AEs following vaginal treatment with the comparator medication [13], our larger study observed a lower percentage (11.4%) in that arm.…”

“…Increased vaginal pH serves as a diagnostic criterion for BV [22]. The Gyno-Türk study reported a baseline mean vaginal pH of 6.1, which significantly decreased to 5.7 on the 10th day visit [13]. Similarly, our study showed improvements in mean vaginal pH values for BV patients across all three treatment arms at the follow-up visit compared to baseline.…”

“…As seen in previous studies, detecting microbiological findings in every patient with clinical symptoms may not always be possible [11,12]. The Gyno-Türk study reported a similar result, where clinical diagnosis did not align with microbiological test results in 21.4% of the patients [13]. While microbiologic tests typically exhibit high sensitivity, disparities between clinician diagnosis and laboratory test results may occur when not all potential causative agents are assessed, as observed in other studies [15].…”

“…In another study, frequencies were 52.2% for BV, 40.6% for VVC, and 7.2% for MVIs [12]. Notably, in the Gyno-Türk study conducted in Türkiye [13], MVIs were diagnosed in 54.1% of the patients, followed by BV (35.7%) and VVC (31.6%) at baseline, with TV was diagnosed in only one patient (1.0%). Cepický et al [14] reported varying rates, like 30% of the symptomatic patients had MVIs, while 15% remained undiagnosed.…”