Trials / Completed
CompletedNCT06056947
Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 577 (actual)
- Sponsor
- Ege University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2021-05-06
- Completion
- 2021-08-26
- First posted
- 2023-09-28
- Last updated
- 2023-09-28
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06056947. Inclusion in this directory is not an endorsement.