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

January 30, 2020 updated by: Exeltis Turkey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35100
        • Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Treatment
Drug: Gynomax® XL Vaginal Ovule
tioconazole, tinidazole, lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with complete response to treatment
Time Frame: 10 Days after completion of treatment
10 Days after completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with partial response to treatment
Time Frame: 10 Days after completion of treatment
10 Days after completion of treatment
Percentage of patients with no response to treatment
Time Frame: 10 Days after completion of treatment
10 Days after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exeltis Turkey

Collaborators

Monitor CRO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2019

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

August 9, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MON564.130.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trichomonal Vaginitis

Clinical Trials on Gynomax® XL Vaginal Ovule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe