Status:
COMPLETED
Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
Lead Sponsor:
Ege University
Collaborating Sponsors:
Monitor CRO
Exeltis Turkey
Conditions:
Trichomonal Vaginitis
Bacterial Vaginosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
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 evalu...
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 fen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
577 Patients enrolled
Trial Details
Trial ID
NCT06056947
Start Date
July 20 2020
End Date
August 26 2021
Last Update
September 28 2023
Active Locations (1)
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1
Ege University Family Planning and Infertility Application and Research Center
Izmir, Turkey (Türkiye)