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

NCT ID: NCT06056947

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-08-26

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.

Conditions

Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

EVEGYN A

Intervention Type: DRUG

EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)

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.

Group Type: EXPERIMENTAL

EVEGYN B

Intervention Type: DRUG

EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)

Gynomax® XL Vaginal Ovule

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

Group Type: ACTIVE_COMPARATOR

Gynomax® XL Vaginal Ovule

Intervention Type: DRUG

200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Gynomax® XL Vaginal Ovule

200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monitor CRO

INDUSTRY

Sponsor Role: collaborator

Exeltis Turkey

INDUSTRY

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Erol Tavmergen, MD

MD Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University Family Planning and Infertility Application and Research Center

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MON580.130.3

Identifier Type: -

Identifier Source: org_study_id