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

Ege University

Status and phase: Completed; Phase 3

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

Treatments: Drug: Gynomax® XL Vaginal Ovule; Drug: EVEGYN B; Drug: EVEGYN A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06056947

MON580.130.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 577 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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577 participants in 3 patient groups

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)

Experimental group

Description:

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

Treatment:

Drug: EVEGYN A

fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)

Experimental group

Description:

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

Treatment:

Drug: EVEGYN B

Gynomax® XL Vaginal Ovule

Active Comparator group

Description:

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

Treatment:

Drug: Gynomax® XL Vaginal Ovule