Evaluation of Efficacy and Safety of Gynomax® XL Ovule

NCT03839875 | Completed Phase 4

• 1 other identifier: MON564.130.1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with complete response to treatment

  10 Days after completion of treatment

Secondary Outcomes (2)

• Percentage of patients with partial response to treatment

  10 Days after completion of treatment

• Percentage of patients with no response to treatment

  10 Days after completion of treatment

Study Arms (1)

Active Treatment

EXPERIMENTAL

Drug: Gynomax® XL Vaginal Ovule

Interventions

Gynomax® XL Vaginal Ovule DRUG

tioconazole, tinidazole, lidocaine

Active Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exeltis Turkey: lead
• Monitor CRO: collaborator

Study Sites (1)

Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trichomonas Vaginitis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Candidiasis; Mycoses; Vulvovaginitis; Vulvitis; Vulvar Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: April 3, 2019
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

TU (1)