Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Bacterial Vaginosis Clinical Trial

— Gyno-Türk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839875
• Other study ID #: MON564.130.1
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2019
• Est. completion date: August 9, 2019

Study information

• Verified date: January 2020
• Source: Exeltis Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidal Vulvovaginitis
• Candidiasis, Vulvovaginal
• Infection
• Mixed Vaginal Infections
• Trichomonal Vaginitis
• Trichomonas Vaginitis
• Vaginal Diseases
• Vaginitis
• Vaginosis, Bacterial
• Vulvovaginitis

Intervention

Drug:
• Gynomax® XL Vaginal Ovule
tioconazole, tinidazole, lidocaine

Locations

Country	Name	City	State
Turkey	Ege University Family Planning and Infertility Application and Research Centerastirma Merkezi	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Exeltis Turkey	Monitor CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete response to treatment		10 Days after completion of treatment
Secondary	Percentage of patients with partial response to treatment		10 Days after completion of treatment
Secondary	Percentage of patients with no response to treatment		10 Days after completion of treatment