Phase
Condition
Sexually Transmitted Diseases (Stds)
Vaginitis
Soft Tissue Infections
Treatment
N/AClinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female patients with age ≥ 18 and ≤ 45 years
Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis or mixedinfections according to the investigator's decision
Signed informed consent
Exclusion
Exclusion Criteria:
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, liverdiseases, benign or malign tumors
Usage of herbal medicines that interfere with microsomal enzymes, especiallycytochrome 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 ortwo 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. accordingto the investigators decision
Study Design
Connect with a study center
Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi
İzmir, 35100
TurkeySite Not Available
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