Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Phase 4

Completed

• Conditions: Bacterial Vaginosis; Candidal Vulvovaginitis; Trichomonal Vaginitis; Mixed Vaginal Infections
• Interventions: Drug: Gynomax® XL Vaginal Ovule

• Registration Number: NCT03839875
• Lead Sponsor: Exeltis Turkey

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Study Start: 2019-04-03
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Treatment	Gynomax® XL Vaginal Ovule	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete response to treatment	10 Days after completion of treatment

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with no response to treatment	10 Days after completion of treatment
Percentage of patients with partial response to treatment	10 Days after completion of treatment

Trial Locations

Locations (1)

Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi; 🇹🇷 İzmir, Turkey