CClinicalTrials.gg
CompletedNCT03839875Gyno-TürkUpdated Jan 31, 2020

Evaluation of Efficacy and Safety of Gynomax® XL Ovule

A Phase 4 interventional study of Gynomax® XL Vaginal Ovule in Trichomonal Vaginitis, Bacterial Vaginosis and Candidal Vulvovaginitis, sponsored by Exeltis Turkey. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-01-31.

Sponsored by Exeltis Turkey · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
116
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Trichomonal Vaginitis
  • Bacterial Vaginosis
  • Candidal Vulvovaginitis
  • Mixed Vaginal Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 116 is close to the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Exeltis Turkey is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    Active Treatment

    Drug: Gynomax® XL Vaginal Ovule

Interventions

  • DrugGynomax® XL Vaginal Ovule

    tioconazole, tinidazole, lidocaine

06

What researchers measure

Primary outcomes

  1. Percentage of patients with complete response to treatment

    Time frame: 10 Days after completion of treatment

Secondary outcomes

  1. Percentage of patients with partial response to treatment

    Time frame: 10 Days after completion of treatment

  2. Percentage of patients with no response to treatment

    Time frame: 10 Days after completion of treatment

07

Study locations

1 site
  • Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi
    İzmir, 35100, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03839875
Lead sponsor
Exeltis Turkey
Collaborators
Monitor CRO
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Apr 3, 2019
Primary completion
Aug 9, 2019
Completion
Aug 9, 2019
Last update
Jan 31, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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