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

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT06056947

Collaborator

Monitor CRO (Industry), Exeltis Turkey (Industry)

577

Enrollment

Location

Arms

13.2

Actual Duration (Months)

43.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trichomonal Vaginitis Bacterial Vaginosis Candidal Vulvovaginitis Mixed Vaginal Infections	Drug: EVEGYN A Drug: EVEGYN B Drug: Gynomax® XL Vaginal Ovule	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

577 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 20, 2020

Actual Primary Completion Date :

May 6, 2021

Actual Study Completion Date :

Aug 26, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Percentage of patients who had complete response to treatment according to clinical findings [13 days (+/- 5 days) after treatment]
Efficacy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Known hypersensitivity to active ingredients (including their derivatives) of the study medications
Vaginismus, endometriosis, dyspareunia
Detection of urinary tract infection in urinalysis
Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
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)
History of cardiovascular event
Uncontrolled diabetes and hypertension
Presence or known risk or of venous or arterial thromboembolism
Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of 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
Chronic alcoholism
Patients with organic neurological disorders
Patients with blood dyscrasia or with a history of blood dyscrasia
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, chlamydia etc. according to the investigator's decision
Patients who cannot perform sexual abstinence during the study
Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder