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OpenTrials
Completed

NCT Number: NCT03839875

Evaluation of Efficacy and Safety of Gynomax® XL Ovule

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gynomax® XL Vaginal Ovule

Drug

tioconazole, tinidazole, lidocaine

Primary outcomes

  1. Percentage of patients with complete response to treatment

    Time frame: 10 Days after completion of treatment

Secondary outcomes

  1. Percentage of patients with partial response to treatment

    Time frame: 10 Days after completion of treatment

  2. Percentage of patients with no response to treatment

    Time frame: 10 Days after completion of treatment

Sponsors and collaborators

Lead sponsor

Exeltis Turkey

Industry

Collaborators

  • Monitor CRO

Registry information

Official study 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

Acronym: Gyno-Türk

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2019
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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