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

Primary Purpose

Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Gynomax® XL Vaginal Ovule

About this trial

This is an interventional treatment trial for Trichomonal Vaginitis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Treatment

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with complete response to treatment

Secondary Outcome Measures

Percentage of patients with partial response to treatment

Percentage of patients with no response to treatment

Full Information

NCT ID

NCT03839875

First Posted

February 11, 2019

Last Updated

January 30, 2020

Sponsor

Exeltis Turkey

Collaborators

Monitor CRO

1. Study Identification

Unique Protocol Identification Number

NCT03839875

Brief Title

Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

April 3, 2019 (Actual)

Primary Completion Date

August 9, 2019 (Actual)

Study Completion Date

August 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exeltis Turkey

Collaborators

Monitor CRO

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gynomax® XL Vaginal Ovule

Intervention Description

tioconazole, tinidazole, lidocaine

Primary Outcome Measure Information:

Title

Percentage of patients with complete response to treatment

Time Frame

10 Days after completion of treatment

Secondary Outcome Measure Information:

Title

Percentage of patients with partial response to treatment

Time Frame

10 Days after completion of treatment

Title

Percentage of patients with no response to treatment

Time Frame

10 Days after completion of treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

City

İzmir

ZIP/Postal Code

35100

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy and Safety of Gynomax® XL Ovule

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