BioavailabilityPhase 1NCT05361369
Bioavailability Study of EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
A Phase 1 study testing EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule in people with Bioavailability, run by Exeltis Turkey at 1 site in Turkey (Türkiye).
Trial summary
A single dose of the study drug will be administered to healthy female subjects in a single period to obtain pharmacokinetic parameters for each active ingredient. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2022to 15 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Hakan Çetinsaya İyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Kayseri
About this study
Official title: A 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
A single dose of the study drug will be administered to healthy female subjects in a single period to obtain pharmacokinetic parameters for each active ingredient.
Read the detailed description
The study drug, EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine. It is manufactured by Exeltis İlaç San. ve Tic. A.Ş., Turkey. It is an antibacterial and antifungal medication that will be used in the treatment of common vaginitis (e.g. bacterial vaginosis, candidal vulvovaginitis). Its efficacy and safety were previously evaluated in a Phase III clinical trial. In this single-center, single-arm, single-dose, bioavailability study, pharmacokinetic parameters for each active ingredient will be evaluated in 18 healthy female subjects following intravaginal administration of this fixed-dose combination.
- Conditions
- Bioavailability
- Being tested
- EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule
- Keywords
- fenticonazole nitrate, tinidazole, lidocaine, fixed-dose combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVEGYN 600 mg/1000 mg/100 mg Vaginal OvuleDrug
Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine
| Study group | Role | What they receive |
|---|---|---|
| EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule | Experimental | Fixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule will be administered once as a single dose during a single-period. Receives: Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations for each analyte
Measured: 0-72 hours
Cmax
Maximum observed plasma concentration for each analyte
Measured: 0-72 hours
Secondary outcomes (4)
Tmax
Time to reach maximum plasma concentration for each analyte
Measured: 0-72 hours
AUC0-inf
Area under the plasma concentration-time profile from time zero to infinity based on observed plasma concentrations for each analyte
Measured: 0-72 hours
T1/2
Half-life for each analyte
Measured: 0-72 hours
Lambda-z
Elimination rate constant for each analyte
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start9 May 2022
- Primary completion13 May 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exeltis Turkey
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361369
- Sponsor's protocol ID
- MON837.130.6
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT05361369
- Acronym / sponsor ID
- MON837.130.6
- Conditions
- Bioavailability
- Keywords
- fenticonazole nitrate, tinidazole, lidocaine, fixed-dose combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Exeltis TurkeyIndustry (pharma, biotech, devices)
- Collaborators
- Monitor CRO
- Study start
- 9 May 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single dose of the study drug will be administered to healthy female subjects in a single period to obtain pharmacokinetic parameters for each active ingredient.
Detailed description
The study drug, EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule, is a fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine. It is manufactured by Exeltis İlaç San. ve Tic. A.Ş., Turkey. It is an antibacterial and antifungal medication that will be used in the treatment of common vaginitis (e.g. bacterial vaginosis, candidal vulvovaginitis). Its efficacy and safety were previously evaluated in a Phase III clinical trial. In this single-center, single-arm, single-dose, bioavailability study, pharmacokinetic parameters for each active ingredient will be evaluated in 18 healthy female subjects following intravaginal administration of this fixed-dose combination.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule | Experimental | Drug: EVEGYN 600 mg/1000 mg/100 mg Vaginal OvuleFixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule will be administered once as a single dose during a single-period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVEGYN 600 mg/1000 mg/100 mg Vaginal OvuleFixed dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine | Drug | EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule |
Primary outcome
AUC0-72
Time frame: 0-72 hours
Area under the plasma concentration-time profile from time zero to 72 hours post dose based on observed plasma concentrations for each analyte
Cmax
Time frame: 0-72 hours
Maximum observed plasma concentration for each analyte
4 secondary outcomes
Tmax
Time frame: 0-72 hours
AUC0-inf
Time frame: 0-72 hours
T1/2
Time frame: 0-72 hours
Lambda-z
Time frame: 0-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVEGYN 600 mg/1000 mg/100 mg Vaginal Ovule in people with Bioavailability, run by Exeltis Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-72 (time frame: 0-72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.