Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections, Trichomonal Vaginitis
Conditions
Brief summary
Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, single-arm, multicentral study.
Interventions
tioconazole, tinidazole, lidocaine
Sponsors
Monitor CRO
Exeltis Turkey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with age ≥ 18 and ≤ 45 years * Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed infections according to the investigator's decision * Signed informed consent
Exclusion criteria
* Known hypersensitivity to active ingredients of the study medications * Vaginismus, endometriosis, dyspareunia * Detection of urinary tract infection in urinalysis * Acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors * Usage of herbal medicines 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) * History of cardiovascular event * Advanced hypertension and diabetes * Presence or known risk or of venous or arterial thromboembolism * Undiagnosed abnormal vaginal bleeding, bleeding disorders, genital tumors * Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study * Pregnancy and/or breastfeeding * Participation in any other trial 30 days before initiation of the study * Postmenopausal women * Abuse of alcohol * Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol * Presence of a sexually transmitted disease such as syphilis, gonorrhea, etc. according to the investigators decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete response to treatment | 10 Days after completion of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with partial response to treatment | 10 Days after completion of treatment |
| Percentage of patients with no response to treatment | 10 Days after completion of treatment |
Countries
Turkey (Türkiye)
Outcome results
None listed