MULTICENTER, RANDOMIZED, OPEN COMPARATIVE CLINICAL STUDY OF THE EFFICACY AND SAFETY OF GYNOMAX XL, VAGINAL SUPPOSITORIES manufactured by EMBIL ILAÇ SANAYI Ltd., Sti (Turkey) with Gynomax, vaginal suppositories manufactured by Embil Ilaç Sanayi Ltd., Sti (Turkey) in the therapy of vulvovaginal candidiasis, bacterial vaginitis, trichomonadal vaginitis or mixed vaginal infections

Phase 3

• Conditions: A59; B37.3; N76; Trichomoniasis; Candidiasis of vulva and vagina; Other inflammation of vagina and vulva

• Registration Number: DRKS00016648
• Lead Sponsor: Exeltis Healthcare S.L. (Spain) Moscow representative office of Exeltis Healthcare S.L. (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-01
• Study Start: 2019-02-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

To participate in the study, patients had to meet the following inclusion criteria:
1. Age from 18 years to 50 years inclusive;
2. Have at least one clinical sign and symptom of vulvovaginal candidiasis, bacterial vaginitis, trichomonal vaginitis or mixed vaginal infection (candidiasis, trichomoniasis, bacterial vaginitis).
3. Positive result of one of laboratory tests – microscopy of Gram-stained smears, pH measurement, amine test, PCR-diagnosis, confirming the presence of pathogen of vulvovaginal candidiasis, bacterial vaginitis, trichomonal vaginitis or mixed vaginal infection.
4. Uncomplicated course of the disease that does not require systemic therapy.
5. Women with preserved reproductive function.
6. A signed informed consent form that confirms in writing the patient’s consent to participate in this clinical study and the patient’s willingness to comply with all the physician’s recommendations during her participation in the clinical study and to be prepared to restrict herself as required by the study.
7. Negative urine pregnancy test and readiness to refrain from having sexual relationships for the entire duration of the CS.
8. First phase of the menstrual cycle after the end of menstrual bleeding.

Exclusion Criteria

Patients should not have been included in the study if they met at least one of the following criteria:
1. Age of the patient of less than 18 years or over 50 years.
2. Known hypersensitivity or suspected hypersensitivity to one or more components of the medicinal product used in the clinical study.
3. Organic diseases of the nervous system at present or in the past.
4. Leukemia, hemopoiesis disorders, blood dyscrasia.
5. History of severe disorders of the liver and kidneys.
6. History of epilepsy.
7. Pregnancy.
8. Lactation period.
9. Virginity.
10. In case of vulvovaginal candidiasis – recurrent course of the disease (more than 4 times a year).
11. Presence of a concomitant STI in the diagnosis.
12. Need for systemic therapy of the disease.
13. Need to be prescribed medicinal products prohibited by the clinical study protocol.
14. Administration of systemic antibacterial medicinal products 4 weeks before being enrolled in the study.
15. Participation in clinical studies 4 weeks before starting to participate in this study.
16. History of alcohol/drug addiction.
17. HIV infection, syphilis, hepatitis B and C virus.
18. Mental disorders requiring medication.
19. Inability or unwillingness of the patient to adhere to the requirements of this clinical study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of cases of clinical recovery on Visit 3 (Day 10) when evaluating therapeutic results.

Secondary Outcome Measures

Name	Time	Method
1. Frequency of cases of clinical recovery on Visit 4 (Day 30) when evaluating therapeutic results.<br>2. Frequency of cases of abatement/disappearance of clinical signs and symptoms of the disease on Visit 2 (Day 4), Visit 3 (Day 10) and Visit 4 (Day 30) in comparison with the baseline data of Visit 1 (Day 0-1).<br>3. Frequency of cases of elimination of the pathogen of infection, revealed by a microbiological study (absence of growth of microorganisms, pathogens) on Visit 3 (Day 10) and Visit 4 (Day 30) in comparison with the baseline data of Visit 1 (Day 0-1).<br>4. Frequency of cases of absence of signs of vulvovaginal candidiasis, bacterial vaginitis, trichomonas vulvovaginitis or mixed vulvovaginal infection in laboratory tests on Visit 3 (Day 10) and Visit 4 (Day 30) compared with baseline data of Visit 1.<br>