Evaluation of Efficacy and Safety of Gynomax® XL Ovule

Last updated: January 30, 2020
Sponsor: Exeltis Turkey
Overall Status: Completed

Phase

4

Condition

Sexually Transmitted Diseases (Stds)

Vaginitis

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03839875
MON564.130.1
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients with age ≥ 18 and ≤ 45 years

  • Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixedinfections according to the investigator's decision

  • Signed informed consent

Exclusion

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, liverdiseases, benign or malign tumors

  • Usage of herbal medicines that interfere with microsomal enzymes, especiallycytochrome 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 ortwo 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. accordingto the investigators decision

Study Design

Total Participants: 116
Study Start date:
April 03, 2019
Estimated Completion Date:
August 09, 2019

Connect with a study center

  • Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

    İzmir, 35100
    Turkey

    Site Not Available

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