Evaluation of Efficacy and Safety of Gynomax® XL Ovule (Gyno-Türk)

Exeltis

Status and phase: Completed; Phase 4

Conditions: Candidal Vulvovaginitis; Mixed Vaginal Infections; Trichomonal Vaginitis; Bacterial Vaginosis

Treatments: Drug: Gynomax® XL Vaginal Ovule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03839875

MON564.130.1

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Active Treatment

Experimental group

Treatment:

Drug: Gynomax® XL Vaginal Ovule