Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Study Overview
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Brief Summary
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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.

Official Title
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A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Efficacy and Safety of Gynomax® XL Ovule in the Treatment of Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis and Mixed Vaginal Infections

Conditions
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Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections

Intervention / Treatment
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* Drug: Gynomax® XL Vaginal Ovule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br> | Drug: Gynomax® XL Vaginal Ovule<br>* tioconazole, tinidazole, lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete response to treatment |  | 10 Days after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |