Completed

EVEGYN Vaginal Ovule Bioavailability Study in Healthy Female Subjects

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the bioavailability of the EVEGYN Vaginal Ovule in healthy female subjects, by measuring the maximum observed plasma concentration and the area under the plasma concentration-time profile from time zero to 72 hours post dose for each analyte.

What is being tested

EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule

Drug
Who is being recruted

From 18 to 55 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 1
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorExeltis Turkey
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 9, 2022

Actual date on which the first participant was enrolled.

This study focuses on a medication called EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, a combination of three drugs: 600 mg fenticonazole nitrate, 1000 mg tinidazole, and 100 mg lidocaine. This medication is designed to combat common vaginal infections like bacterial vaginosis and candidal vulvovaginitis. The study aims to understand how this medication works in the body and how safe it is. It's being conducted with 18 healthy female participants, as the medication is intended for women's health. The results of this study could help improve treatment options for common vaginal infections. In this study, each participant receives a single dose of the medication, which is administered intravaginally. The study then measures how the body responds to each of the three drugs in the medication over a period of 72 hours. The response is measured by looking at the maximum concentration of each drug in the bloodstream and the area under the plasma concentration-time curve, which shows how the concentration of the drug changes over time. This helps researchers understand how the body absorbs and processes the medication.

Official TitleA Single Center, Single Arm, Single Dose, Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule (a Fixed Dose Combination of 600 mg Fenticonazole Nitrate + 1000 mg Tinidazole + 100 mg Lidocaine) in 18 Healthy Female Subjects
NCT05361369
Principal SponsorExeltis Turkey
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Healthy female adult subject with age of >= 18 and <= 55 years who have a regular menstrual cycle (at least 10 times a year)

Subject with a body weight >= 50 kg and body mass index between 16 and 30 kg/m2

Informed consent signed by the subject

4 exclusion criteria prevent from participating
Positive rapid antigen or polymerase chain reaction test result for COVID-19

Pregnancy and/or breastfeeding, or subject who doesn't accept not to get pregnant during the study

Known hypersensitivity to active ingredients (including their derivatives) of the study medication

Postmenopausal women

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive a one-time dose of EVEGYN, a combination of fenticonazole nitrate, tinidazole, and lidocaine.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, Turkey (Türkiye)Open Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP) in Google Maps
CompletedOne Study Center