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

• Status: Completed
• Trial end date: 2021-08-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ege University
• Collaborators: Exeltis Turkey; Monitor CRO

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