Last updated: September 25, 2023
Sponsor: Ege University
Overall Status: Completed
Phase
3
Condition
Cutaneous Candidiasis
Sexually Transmitted Diseases (Stds)
Soft Tissue Infections
Treatment
EVEGYN B
EVEGYN A
Gynomax® XL Vaginal Ovule
Clinical Study ID
NCT06056947
MON580.130.3
Ages 18-55 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (atleast 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
Exclusion Criteria:
- Known hypersensitivity to active ingredients (including their derivatives) of thestudy medications
- Vaginismus, endometriosis, dyspareunia
- Detection of urinary tract infection in urinalysis
- Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors andongoing organ failure
- Usage of herbal medicines and drugs 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
- Uncontrolled diabetes and hypertension
- Presence or known risk or of venous or arterial thromboembolism
- Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due tointrauterine device implantation during study period, presence of 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
- 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 otheranatomical disorder
Study Design
Total Participants: 577
Treatment Group(s): 3
Primary Treatment: EVEGYN B
Phase: 3
Study Start date:
July 20, 2020
Estimated Completion Date:
August 26, 2021
Study Description
Connect with a study center
Ege University Family Planning and Infertility Application and Research Center
Izmir,
TurkeySite Not Available
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