Trichomonal VaginitisPhase 4Gyno-TürkNCT03839875
Evaluation of Efficacy and Safety of Gynomax® XL Ovule
A Phase 4 study testing Gynomax® XL Vaginal Ovule in people with Trichomonal Vaginitis and Bacterial Vaginosis, run by Exeltis Turkey at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis
- What is being tested?
- Gynomax® XL Vaginal Ovule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2019to 9 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Family Planning and Infertility Application and Research Centeraştırma Merkezi
Izmir, 35100
About this study
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
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
- Being tested
- Gynomax® XL Vaginal Ovule
- Medical subject headings
- Trichomonas Vaginitis, Vaginosis, Bacterial, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynomax® XL Vaginal OvuleDrug
tioconazole, tinidazole, lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Not described Receives: Drug: Gynomax® XL Vaginal Ovule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete response to treatment
Measured: 10 Days after completion of treatment
Secondary outcomes (2)
Percentage of patients with partial response to treatment
Measured: 10 Days after completion of treatment
Percentage of patients with no response to treatment
Measured: 10 Days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start3 Apr 2019
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonal VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exeltis Turkey
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839875
- Sponsor's protocol ID
- MON564.130.1
- Acronym
- Gyno-Türk
- Status last verified
- Jan 2020
- First submitted
- 11 Feb 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03839875
- Acronym / sponsor ID
- Gyno-Türk / MON564.130.1
- Conditions
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Exeltis TurkeyIndustry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Gynomax® XL Vaginal Ovule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynomax® XL Vaginal Ovuletioconazole, tinidazole, lidocaine | Drug | Active Treatment |
Primary outcome
Percentage of patients with complete response to treatment
Time frame: 10 Days after completion of treatment
2 secondary outcomes
Percentage of patients with partial response to treatment
Time frame: 10 Days after completion of treatment
Percentage of patients with no response to treatment
Time frame: 10 Days after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gynomax® XL Vaginal Ovule in people with Trichomonal Vaginitis and Bacterial Vaginosis, run by Exeltis Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete response to treatment (time frame: 10 Days after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.