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Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule (One-Shot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056947
Recruitment Status : Completed
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Collaborators:
Monitor CRO
Exeltis Turkey
Information provided by (Responsible Party):
Erol Tavmergen, MD, Ege University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Trichomonal Vaginitis Bacterial Vaginosis Candidal Vulvovaginitis Mixed Vaginal Infections Drug: EVEGYN A Drug: EVEGYN B Drug: Gynomax® XL Vaginal Ovule Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2020
Actual Primary Completion Date : May 6, 2021
Actual Study Completion Date : August 26, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tinidazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN A)
EVEGYN A is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule.
 Drug: EVEGYN A
EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Experimental: fenticonazole + tinidazole + lidocaine vaginal ovule (EVEGYN B)
EVEGYN B is a fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule.
 Drug: EVEGYN B
EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1)
Active Comparator: Gynomax® XL Vaginal Ovule
Gynomax® XL is a fixed-dose combination of 300 mg tinidazole + 200 mg tioconazole nitrate + 100 mg lidocaine
 Drug: Gynomax® XL Vaginal Ovule
200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who had complete response to treatment according to clinical findings [ Time Frame: 13 days (+/- 5 days) after treatment ]
    Efficacy


Secondary Outcome Measures :
  1. Percentage of patients who had partial response to treatment according to clinical findings [ Time Frame: 13 days (+/- 5 days) after treatment ]
    Efficacy

  2. Percentage of patients who recovered according to microbiological findings [ Time Frame: 13 days (+/- 5 days) after treatment ]
    Efficacy

  3. Frequency and percentage of patients with SAEs/AEs in each arm [ Time Frame: 13 days (+/- 5 days) ]
    Safety


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients with age of ≥ 18 and ≤ 55 years who have a regular menstrual cycle (at least 10 times a year)
  2. Female patients who previously experienced vaginal intercourse
  3. Patients requiring treatment for bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis or mixed infections according to the investigator's decision
  4. Signed informed consent

Exclusion Criteria:

  1. Known hypersensitivity to active ingredients (including their derivatives) of the study medications
  2. Vaginismus, endometriosis, dyspareunia
  3. Detection of urinary tract infection in urinalysis
  4. Pancreatitis, hypertriglyceridemia, liver diseases, benign or malign tumors and ongoing organ failure
  5. 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)
  6. History of cardiovascular event
  7. Uncontrolled diabetes and hypertension
  8. Presence or known risk or of venous or arterial thromboembolism
  9. Undiagnosed abnormal vaginal bleeding, bleeding disorders, bleeding due to intrauterine device implantation during study period, presence of genital tumors
  10. Use of drugs containing ombitasvir / paritaprevir / ritonavir or dasabuvir during or two weeks before initiation of the study
  11. Pregnancy and/or breastfeeding
  12. Participation in any other trial 30 days before initiation of the study
  13. Postmenopausal women
  14. Chronic alcoholism
  15. Patients with organic neurological disorders
  16. Patients with blood dyscrasia or with a history of blood dyscrasia
  17. Usage of medications containing acenocoumarol, anisindione, dicoumarol, phenindione, phenprocoumon, warfarin, cholestyramine, cimetidine, cyclosporine, disulfiram, fluorouracil, fosphenitoin, ketoconazole, lithium, rifampin, tacrolimus or propranolol
  18. Presence of a sexually transmitted disease such as syphilis, gonorrhea, chlamydia etc. according to the investigator's decision
  19. Patients who cannot perform sexual abstinence during the study
  20. Patients whose treatment may be affected due to sagging of uterus or any other anatomical disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056947


Locations
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Turkey
Ege University Family Planning and Infertility Application and Research Center
Izmir, Turkey
Sponsors and Collaborators
Ege University
Monitor CRO
Exeltis Turkey
More Information
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Responsible Party: Erol Tavmergen, MD, MD Prof, Ege University
ClinicalTrials.gov Identifier: NCT06056947    
Other Study ID Numbers: MON580.130.3
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Trichomonas Vaginitis
Vaginal Diseases
Vaginitis
Vulvovaginitis
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Genital Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Vulvitis
Vulvar Diseases
Candidiasis
Mycoses
Trichomonas Infections
Protozoan Infections
Parasitic Diseases