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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839875
Other study ID # MON564.130.1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 3, 2019
Est. completion date August 9, 2019

Study information

Verified date January 2020
Source Exeltis Turkey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date August 9, 2019
Est. primary completion date August 9, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Gynomax® XL Vaginal Ovule
tioconazole, tinidazole, lidocaine

Locations

Country Name City State
Turkey Ege University Family Planning and Infertility Application and Research Centerastirma Merkezi Izmir

Sponsors (2)

Lead Sponsor Collaborator
Exeltis Turkey Monitor CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with complete response to treatment 10 Days after completion of treatment
Secondary Percentage of patients with partial response to treatment 10 Days after completion of treatment
Secondary Percentage of patients with no response to treatment 10 Days after completion of treatment
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