Clinical trial NCT03839875: Evaluation of Efficacy and Safety of Gynomax® XL Ovule
Official title: A National, Multi-central, Open-label, Single-arm, Phase IV Study to Evaluate Efficacy and Safety of Gynomax® XL Ovule in the Treatment of Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis and Mixed Vaginal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trichomonal Vaginitis
Bacterial Vaginosis
Candidal Vulvovaginitis
Mixed Vaginal Infections
Lead sponsor: Exeltis Turkey
Sponsor class: INDUSTRY
Collaborators: name: Monitor CRO
First posted: 2019-02-15
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, single-arm, multicentral study.


Eligibility criteria: Inclusion Criteria:

* 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 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, 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

Primary outcomes:
measure: Percentage of patients with complete response to treatment
timeFrame: 10 Days after completion of treatment
Secondary outcomes:
measure: Percentage of patients with partial response to treatment
timeFrame: 10 Days after completion of treatment
measure: Percentage of patients with no response to treatment
timeFrame: 10 Days after completion of treatment
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi
Study officials:
References: