Trichomonal VaginitisPhase 3One-ShotNCT06056947
Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
A Phase 3 study testing EVEGYN A, EVEGYN B and Gynomax® XL Vaginal Ovule in people with Trichomonal Vaginitis and Bacterial Vaginosis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis
- What is being tested?
- EVEGYN A, EVEGYN B and Gynomax® XL Vaginal Ovule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 577 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2020to 26 Aug 2021
- Phase
- Phase 3
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
- Female patients who previously experienced vaginal intercourse
- Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
- Signed informed consent
Who cannot join
- Known hypersensitivity to active ingredients (including their derivatives) of the study medications
- Vaginismus, endometriosis, dyspareunia
- Detection of urinary tract infection in urinalysis
- Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
- Usage of herbal medicines and drugs 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 20Show fewer
- Uncontrolled diabetes and hypertension
- Presence or known risk or of venous or arterial thromboembolism
- Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of 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
- Chronic alcoholism
- Patients with organic neurological disorders
- Patients with blood dyscrasia or with a history of blood dyscrasia
- 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, chlamydia etc. according to the investigator's decision
- Patients who cannot perform sexual abstinence during the study
- Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Family Planning and Infertility Application and Research Center
Izmir
About this study
Official title: Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections
Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
Read the detailed description
This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye.
It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule.
- Conditions
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections
- Being tested
- EVEGYN A, EVEGYN B, 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.
EVEGYN ADrug
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
EVEGYN BDrug
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Gynomax® XL Vaginal OvuleDrug
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
| Study group | Role | What they receive |
|---|---|---|
| fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A) | Experimental | EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule. Receives: Drug: EVEGYN A |
| fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B) | Experimental | EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule. Receives: Drug: EVEGYN B |
| Gynomax® XL Vaginal Ovule | Active comparator | Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine 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 who had complete response to treatment according to clinical findings
Efficacy
Measured: 13 days (+/- 5 days) after treatment
Secondary outcomes (3)
Percentage of patients who had partial response to treatment according to clinical findings
Efficacy
Measured: 13 days (+/- 5 days) after treatment
Percentage of patients who recovered according to microbiological findings
Efficacy
Measured: 13 days (+/- 5 days) after treatment
Frequency and percentage of patients with SAEs/AEs in each arm
Safety
Measured: 13 days (+/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Jul 2020
- Primary completion6 May 2021
- Study completion26 Aug 2021
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.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Monitor CRO, Exeltis Turkey
- Responsible party
- Principal investigator, Erol Tavmergen, MD, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056947
- Sponsor's protocol ID
- MON580.130.3
- Acronym
- One-Shot
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Evaluate Efficacy and Safety of Different Formulations of Fenticonazole + Tinidazole + Lidocaine in the Treatment of Bacterial Vaginosis, Candidal Vulvovaginitis, Trichomonal Vaginitis and Mixed Infections
- ClinicalTrials.gov ID
- NCT06056947
- Acronym / sponsor ID
- One-Shot / MON580.130.3
- Conditions
- Trichomonal Vaginitis, Bacterial Vaginosis, Candidal Vulvovaginitis, Mixed Vaginal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Monitor CRO, Exeltis Turkey
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 28 Sep 2023 (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 two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
Detailed description
This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye.
It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and mixed infections with comparison to Gynomax® XL vaginal ovule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A) | Experimental | Drug: EVEGYN AEVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule. |
| fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B) | Experimental | Drug: EVEGYN BEVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule. |
| Gynomax® XL Vaginal Ovule | Active comparator | Drug: Gynomax® XL Vaginal OvuleGynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
- Female patients who previously experienced vaginal intercourse
- Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
- Signed informed consent
Key exclusion criteria (20 listed)
- Known hypersensitivity to active ingredients (including their derivatives) of the study medications
- Vaginismus, endometriosis, dyspareunia
- Detection of urinary tract infection in urinalysis
- Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
- Usage of herbal medicines and drugs 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 |
|---|---|---|
| EVEGYN AEVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1) | Drug | fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A) |
| EVEGYN BEVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1) | Drug | fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B) |
| Gynomax® XL Vaginal Ovule200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days) | Drug | Gynomax® XL Vaginal Ovule |
Primary outcome
Percentage of patients who had complete response to treatment according to clinical findings
Time frame: 13 days (+/- 5 days) after treatment
Efficacy
3 secondary outcomes
Percentage of patients who had partial response to treatment according to clinical findings
Time frame: 13 days (+/- 5 days) after treatment
Percentage of patients who recovered according to microbiological findings
Time frame: 13 days (+/- 5 days) after treatment
Frequency and percentage of patients with SAEs/AEs in each arm
Time frame: 13 days (+/- 5 days)
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 28 Sep 2023.
- Individual participant dataSharing planned: No
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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 3 study testing EVEGYN A, EVEGYN B and Gynomax® XL Vaginal Ovule in people with Trichomonal Vaginitis and Bacterial Vaginosis, run by Ege University 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 4 inclusion and 20 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 28 Sep 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 who had complete response to treatment according to clinical findings (time frame: 13 days (+/- 5 days) after 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 28 Sep 2023.