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- Title
The Efficacy and Safety of Gynomax® XL Vaginal Ovule in the Treatment of Common Vaginal Infections: A Single-Arm Clinical Trial, Gyno-Türk.
- Authors
TAVMERGEN, Erol; ACET, Ferruh; TANER, Cüneyt Eftal; DURMUŞOĞLU, Fatih; ÜSTÜN, Yaprak; DİLBAZ, Berna; ÇİLLİ, Fatma Feriha
- Abstract
Objective: 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.
- Subjects
TIOCONAZOLE; DRUG efficacy; MEDICATION safety; VAGINAL disease treatment; CLINICAL trials; DRUG tolerance
- Publication
Journal of Clinical Obstetrics & Gynecology, 2021, Vol 31, Issue 4, p120
- ISSN
2619-9467
- Publication type
Article
- DOI
10.5336/jcog.2021-85924