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

Bacterial Vaginosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06056947
• Other study ID #: MON580.130.3
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2020
• Est. completion date: August 26, 2021

Study information

• Verified date: September 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: August 26, 2021
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidal Vulvovaginitis
• Candidiasis, Vulvovaginal
• Infections
• Mixed Vaginal Infections
• Trichomonal Vaginitis
• Trichomonas Vaginitis
• Vaginal Diseases
• Vaginitis
• Vaginosis, Bacterial
• Vulvovaginitis

Intervention

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)
• 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)
• Gynomax® XL Vaginal Ovule
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

Locations

Country	Name	City	State
Turkey	Ege University Family Planning and Infertility Application and Research Center	Izmir

Sponsors (3)

Lead Sponsor	Collaborator
Ege University	Exeltis Turkey, Monitor CRO

Country where clinical trial is conducted

Turkey, 

Outcome

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