Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule (One-Shot)

Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections

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.

Study Overview

• Status: Completed
• Conditions: Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections
• Intervention / Treatment: Drug: EVEGYN A; Drug: EVEGYN B; Drug: Gynomax® XL Vaginal Ovule

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 577
• Phase: Phase 3

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Ege University Family Planning and Infertility Application and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 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 Criteria:

1. Known hypersensitivity to active ingredients (including their derivatives) of the study medications
2. Vaginismus, endometriosis, dyspareunia
3. Detection of urinary tract infection in urinalysis
4. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
5. Usage of herbal medicines and drugs 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)
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 to intrauterine device implantation during study period, presence of genital tumors
10. Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two 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 other anatomical disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A); EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.	Drug: EVEGYN A; EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B); EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.	Drug: EVEGYN B; EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Active Comparator: Gynomax® XL Vaginal Ovule; Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine	Drug: Gynomax® XL Vaginal Ovule; 200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who had complete response to treatment according to clinical findings	Efficacy	13 days (+/- 5 days) after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who had partial response to treatment according to clinical findings	Efficacy	13 days (+/- 5 days) after treatment
Percentage of patients who recovered according to microbiological findings	Efficacy	13 days (+/- 5 days) after treatment
Frequency and percentage of patients with SAEs/AEs in each arm	Safety	13 days (+/- 5 days)

Collaborators and Investigators

• Sponsor: Ege University
• Collaborators: Exeltis Turkey; Monitor CRO

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): May 6, 2021
• Study Completion (Actual): August 26, 2021

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Protozoan Infections; Mycoses; Vulvar Diseases; Vulvitis; Candidiasis; Trichomonas Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infections; Vaginal Diseases; Vaginitis; Vaginosis, Bacterial; Vulvovaginitis; Candidiasis, Vulvovaginal; Trichomonas Vaginitis
• Other Study ID Numbers: MON580.130.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No