Evaluation of Efficacy and Safety of Gynomax® XL Ovule

NCT ID: NCT03839875

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2019-08-09

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment

Group Type: EXPERIMENTAL

Gynomax® XL Vaginal Ovule

Intervention Type: DRUG

tioconazole, tinidazole, lidocaine

Interventions

Gynomax® XL Vaginal Ovule

tioconazole, tinidazole, lidocaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monitor CRO

INDUSTRY

Sponsor Role: collaborator

Exeltis Turkey

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MON564.130.1

Identifier Type: -

Identifier Source: org_study_id