Bacterial Vaginosis Clinical Trial
— One-ShotOfficial title:
Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections
Verified date | September 2023 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
Status | Completed |
Enrollment | 577 |
Est. completion date | August 26, 2021 |
Est. primary completion date | May 6, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. Female patients with age of = 18 and = 55 years who have a regular menstrual cycle (at least 10 times a year) 2. Female patients who previously experienced vaginal intercourse 3. Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision 4. Signed informed consent Exclusion Criteria: 1. Known hypersensitivity to active ingredients (including their derivatives) of the study medications 2. Vaginismus, endometriosis, dyspareunia 3. Detection of urinary tract infection in urinalysis 4. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure 5. Usage of herbal medicines and drugs that interfere with microsomal enzymes, especially cytochrome P450 (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, topiramate, felbamate, griseofulvin, HIV protease inhibitors such as ritonavir, nucleoside reverse transcriptase inhibitors such as efavirenz) 6. History of cardiovascular event 7. Uncontrolled diabetes and hypertension 8. Presence or known risk or of venous or arterial thromboembolism 9. Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of genital tumors 10. Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study 11. Pregnancy and/or breastfeeding 12. Participation in any other trial 30 days before initiation of the study 13. Postmenopausal women 14. Chronic alcoholism 15. Patients with organic neurological disorders 16. Patients with blood dyscrasia or with a history of blood dyscrasia 17. Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol 18. Presence of a sexually transmitted disease such as syphilis, gonorrhea, chlamydia etc. according to the investigator's decision 19. Patients who cannot perform sexual abstinence during the study 20. Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University Family Planning and Infertility Application and Research Center | Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University | Exeltis Turkey, Monitor CRO |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients who had complete response to treatment according to clinical findings | Efficacy | 13 days (+/- 5 days) after treatment | |
Secondary | Percentage of patients who had partial response to treatment according to clinical findings | Efficacy | 13 days (+/- 5 days) after treatment | |
Secondary | Percentage of patients who recovered according to microbiological findings | Efficacy | 13 days (+/- 5 days) after treatment | |
Secondary | Frequency and percentage of patients with SAEs/AEs in each arm | Safety | 13 days (+/- 5 days) |
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