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

Primary Purpose

Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
EVEGYN A
EVEGYN B
Gynomax® XL Vaginal Ovule
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichomonal Vaginitis

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Ege University Family Planning and Infertility Application and Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)

Gynomax® XL Vaginal Ovule

Arm Description

EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.

EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.

Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine

Outcomes

Primary Outcome Measures

Percentage of patients who had complete response to treatment according to clinical findings
Efficacy

Secondary Outcome Measures

Percentage of patients who had partial response to treatment according to clinical findings
Efficacy
Percentage of patients who recovered according to microbiological findings
Efficacy
Frequency and percentage of patients with SAEs/AEs in each arm
Safety

Full Information

First Posted
September 13, 2023
Last Updated
September 25, 2023
Sponsor
Ege University
Collaborators
Monitor CRO, Exeltis Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT06056947
Brief Title
Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
Acronym
One-Shot
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
Monitor CRO, Exeltis Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
577 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)
Arm Type
Experimental
Arm Description
EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.
Arm Title
fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)
Arm Type
Experimental
Arm Description
EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.
Arm Title
Gynomax® XL Vaginal Ovule
Arm Type
Active Comparator
Arm Description
Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine
Intervention Type
Drug
Intervention Name(s)
EVEGYN A
Intervention Description
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Intervention Type
Drug
Intervention Name(s)
EVEGYN B
Intervention Description
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Intervention Type
Drug
Intervention Name(s)
Gynomax® XL Vaginal Ovule
Intervention Description
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
Primary Outcome Measure Information:
Title
Percentage of patients who had complete response to treatment according to clinical findings
Description
Efficacy
Time Frame
13 days (+/- 5 days) after treatment
Secondary Outcome Measure Information:
Title
Percentage of patients who had partial response to treatment according to clinical findings
Description
Efficacy
Time Frame
13 days (+/- 5 days) after treatment
Title
Percentage of patients who recovered according to microbiological findings
Description
Efficacy
Time Frame
13 days (+/- 5 days) after treatment
Title
Frequency and percentage of patients with SAEs/AEs in each arm
Description
Safety
Time Frame
13 days (+/- 5 days)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ege University Family Planning and Infertility Application and Research Center
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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