NCT06056947 - Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule | Biotech Hunter

Enrollment

577

Participants

Timeline

Start Date

July 20, 2020

Primary Completion Date

May 6, 2021

Study Completion Date

August 26, 2021

Conditions

Trichomonal VaginitisBacterial VaginosisCandidal VulvovaginitisMixed 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)

Trial Locations (1)

Unknown

Ege University Family Planning and Infertility Application and Research Center, Izmir