Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

Last updated: September 25, 2023
Sponsor: Ege University
Overall Status: Completed

Phase

3

Condition

Cutaneous Candidiasis

Sexually Transmitted Diseases (Stds)

Soft Tissue Infections

Treatment

EVEGYN B

EVEGYN A

Gynomax® XL Vaginal Ovule

Clinical Study ID

NCT06056947
MON580.130.3
  • Ages 18-55
  • Female

Study Summary

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (atleast 10 times a year)
  2. Female patients who previously experienced vaginal intercourse
  3. Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis,trichomonal vaginitis or mixed infections according to the investigator's decision
  4. Signed informed consent

Exclusion

Exclusion Criteria:

  1. Known hypersensitivity to active ingredients (including their derivatives) of thestudy medications
  2. Vaginismus, endometriosis, dyspareunia
  3. Detection of urinary tract infection in urinalysis
  4. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors andongoing organ failure
  5. Usage of herbal medicines and drugs 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)
  6. History of cardiovascular event
  7. Uncontrolled diabetes and hypertension
  8. Presence or known risk or of venous or arterial thromboembolism
  9. Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due tointrauterine device implantation during study period, presence of genital tumors
  10. Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during ortwo weeks before initiation of the study
  11. Pregnancy and/or breastfeeding
  12. Participation in any other trial 30 days before initiation of the study
  13. Postmenopausal women
  14. Chronic alcoholism
  15. Patients with organic neurological disorders
  16. Patients with blood dyscrasia or with a history of blood dyscrasia
  17. Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione,phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram,fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol
  18. Presence of a sexually transmitted disease such as syphilis, gonorrhea, chlamydia etc.according to the investigator's decision
  19. Patients who cannot perform sexual abstinence during the study
  20. Patients whose treatment may be affected due to sagging of uterus or any otheranatomical disorder

Study Design

Total Participants: 577
Treatment Group(s): 3
Primary Treatment: EVEGYN B
Phase: 3
Study Start date:
July 20, 2020
Estimated Completion Date:
August 26, 2021

Study Description

This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye.

It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule.

Connect with a study center

  • Ege University Family Planning and Infertility Application and Research Center

    Izmir,
    Turkey

    Site Not Available

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