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

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ClinicalTrials.gov Identifier: NCT03839875
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Monitor CRO
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Trichomonal Vaginitis Bacterial Vaginosis Candidal Vulvovaginitis Mixed Vaginal Infections Drug: Gynomax® XL Vaginal Ovule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Percentage of patients with complete response to treatment [ Time Frame: 10 Days after completion of treatment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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Responsible Party: Exeltis Turkey
ClinicalTrials.gov Identifier: NCT03839875     History of Changes
Other Study ID Numbers: MON564.130.1
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Vaginal Diseases
Vaginosis, Bacterial
Vaginitis
Vulvovaginitis
Candidiasis, Vulvovaginal
Trichomonas Vaginitis
Genital Diseases, Female
Bacterial Infections
Vulvitis
Vulvar Diseases
Candidiasis
Mycoses
Trichomonas Infections
Protozoan Infections
Parasitic Diseases