Status:
COMPLETED
Evaluation of Efficacy and Safety of Gynomax® XL Ovule
Lead Sponsor:
Exeltis Turkey
Collaborating Sponsors:
Monitor CRO
Conditions:
Trichomonal Vaginitis
Bacterial Vaginosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Efficacy and safety of Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections will be evaluated in this open label, sing...
Eligibility Criteria
Inclusion
- Female patients with age ≥ 18 and ≤ 45 years
- Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixed infections according to the investigator's decision
- Signed informed consent
Exclusion
- Known hypersensitivity to active ingredients of the study medications
- Vaginismus, endometriosis, dyspareunia
- Detection of urinary tract infection in urinalysis
- Acute or chronic infections such as pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors
- Usage of herbal medicines 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
- Advanced hypertension and diabetes
- Presence or known risk or of venous or arterial thromboembolism
- Undiagnosed abnormal vaginal bleeding, bleeding disorders, 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
- Abuse of alcohol
- 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, etc. according to the investigators decision
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03839875
Start Date
April 3 2019
End Date
August 9 2019
Last Update
January 31 2020
Active Locations (1)
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1
Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi
Izmir, Turkey (Türkiye), 35100