MedTrace Logo

Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

NCT06056947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Trichomonal Vaginitis
  • Bacterial Vaginosis
  • Candidal Vulvovaginitis
  • Mixed Vaginal Infections

Interventions

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)

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)

DRUG

Gynomax® XL Vaginal Ovule

200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)

Sponsors & Collaborators

  • Monitor CRO

    collaborator INDUSTRY

  • Exeltis Turkey

    collaborator INDUSTRY

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2021-05-06
Completion
2021-08-26

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06056947 on ClinicalTrials.gov