A Phase 3 interventional study of EVEGYN A and EVEGYN B in Trichomonal Vaginitis, Bacterial Vaginosis and Candidal Vulvovaginitis, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Ege University · Phase 3, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Trichomonas Vaginitis; 3 are open to participants now.
This study's enrollment of 577 is above the median of 351 across 15 interventional studies indexed under Trichomonas Vaginitis.
Browse Trichomonas Vaginitis studies →Ege University is the lead sponsor of 376 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.
Drug: EVEGYN A
EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.
Drug: EVEGYN B
Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine
Drug: Gynomax® XL Vaginal Ovule
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
Percentage of patients who had complete response to treatment according to clinical findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Percentage of patients who had partial response to treatment according to clinical findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Percentage of patients who recovered according to microbiological findings
Efficacy
Time frame: 13 days (+/- 5 days) after treatment
Frequency and percentage of patients with SAEs/AEs in each arm
Safety
Time frame: 13 days (+/- 5 days)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in May 2021, 9 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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