Trichomonas VaginitisNCT05383521
Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis
A study testing Tinidazole 56 and Tinidazole 42 in people with Trichomonas Vaginitis, run by Shangrong Fan at 4 sites in China.
Trial summary
We compare two oral tinidazole regimens for refractory trichomonas vaginitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Trichomonas Vaginitis
- What is being tested?
- Tinidazole 56 and Tinidazole 42
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesChina
- Study dates
- 1 Dec 2025to 30 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women be at least 18 years of age
- Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)
Who cannot join
- Allergy to metronidazole or tinidazol
- Pregnant or nursing
- HIV or other chronic disease
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing
Zhaohui Liu, M.D.
Zhaohui Liu
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Beijing
Qinping Liao, M.D.
Qinping Liao
Peking University First Hospital
Beijing
Dai Zhang, M.D.
Dai Zhang
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Yiheng liang, M.D., 86-755-83923333 ext. 5518, 13510331823@163.com
Ping liu, M.D., 86-755-83923333 ext. 5505, 253783006@qq.com
About this study
Official title: Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
Read the detailed description
Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.
- Conditions
- Trichomonas Vaginitis
- Being tested
- Tinidazole 56, Tinidazole 42
- Keywords
- Refractory Trichomonas Vaginitis, Tinidazole
- Medical subject headings
- Trichomonas Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinidazole 56Drug
Also called Tinidazole M56
Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
Tinidazole 42Drug
Also called Tinidazole M42
Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tinidazole 56 | Experimental | Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. Receives: Drug: Tinidazole 42 |
| Tinidazole 42 | Experimental | Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. Receives: Drug: Tinidazole 56 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of refractory trichomoniasis
Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination.
Measured: 24 weeks
Secondary outcomes (1)
Safety of tinidazole tablets
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Test of blood routine,liver function, kidney function ,and urine routine will be done before treatment.The same test will be were reviewed within 1 week after treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichomonas VaginitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days. Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shangrong Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Shangrong Fan Fan, M.D., Principal investigator, Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383521
- Sponsor's protocol ID
- 2020PUSZH001
- Status last verified
- Jun 2024
- First submitted
- 5 Jan 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis
- ClinicalTrials.gov ID
- NCT05383521
- Acronym / sponsor ID
- 2020PUSZH001
- Conditions
- Trichomonas Vaginitis
- Keywords
- Refractory Trichomonas Vaginitis, Tinidazole
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shangrong FanUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 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.
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
Detailed description
Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For patients who failed to conventional treatment (recommended by the guidelines including tinidazole, 2g once daily for 5-7 days), the following regimens were selected: Tinidazole , 2g twice daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days. Tinidazole , 1g three times daily for 14 days. At the same time, metronidazole, 400 mg, daily, vaginal administration for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Tinidazole 56 | Experimental | Drug: Tinidazole 42Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. |
| Tinidazole 42 | Experimental | Drug: Tinidazole 56Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women be at least 18 years of age
- Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)
Key exclusion criteria (3 listed)
- Allergy to metronidazole or tinidazol
- Pregnant or nursing
- HIV or other chronic disease
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 |
|---|---|---|
| Tinidazole 56Also: Tinidazole M56Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. | Drug | Tinidazole 42 |
| Tinidazole 42Also: Tinidazole M42Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days. | Drug | Tinidazole 56 |
Primary outcome
Cure rate of refractory trichomoniasis
Time frame: 24 weeks
Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination.
1 secondary outcome
Safety of tinidazole tablets
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
Shangrong Fan Fan, M.D. principal investigator
Peking University Shenzhen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinidazole 56 and Tinidazole 42 in people with Trichomonas Vaginitis, run by Shangrong Fan at 4 sites in China.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiheng Liang, M.D. (86-755-83923333 ext. 5518, 13510331823@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of refractory trichomoniasis (time frame: 24 weeks). 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 11 Jun 2024.