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Not yet recruitingNCT05383521Updated Jun 11, 2024

Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis

An interventional study of Tinidazole 56 and Tinidazole 42 in Trichomonas Vaginitis, sponsored by Shangrong Fan. Not yet recruiting at 4 sites in China. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by Shangrong Fan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Trichomonas Vaginitis

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Keywords

  • Refractory Trichomonas Vaginitis
  • Tinidazole
03

In context

Trichomonas Vaginitis

22 studies on the registry are indexed under Trichomonas Vaginitis; 3 are open to participants now.

This study's planned enrollment of 20 is below the median of 351 across 15 interventional studies indexed under Trichomonas Vaginitis.

Browse Trichomonas Vaginitis studies →

Lead sponsor

This is the only study on the registry with Shangrong Fan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women be at least 18 years of age
  • Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)

Exclusion criteria

Exclusion Criteria:

  • Allergy to metronidazole or tinidazol
  • Pregnant or nursing
  • or other chronic disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Tinidazole 56

    Tinidazole , 2g, twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

    Drug: Tinidazole 42

  • Experimental
    Tinidazole 42

    Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

    Drug: Tinidazole 56

Interventions

  • DrugTinidazole 56

    Tinidazole , 2g, twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

    Also known as: Tinidazole M56

  • DrugTinidazole 42

    Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.

    Also known as: Tinidazole M42

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 24 weeks

07

Study locations

4 sites
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong 518000, China
    • Yiheng liang, M.D. · Contact13510331823@163.com · 86-755-83923333
    • Ping liu, M.D. · Contact253783006@qq.com · 86-755-83923333
    • Shangrong Fan, MD · Principal investigator
  • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
    Peking, China
    • Zhaohui Liu, M.D. · Contact
    • Zhaohui Liu · Principal investigator
  • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
    Peking, China
    • Qinping Liao, M.D. · Contact
    • Qinping Liao · Principal investigator
  • Peking University First Hospital
    Peking, China
    • Dai Zhang, M.D. · Contact
    • Dai Zhang · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2025; primary completion for Dec 2025, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2021
First posted
May 20, 2022
StartEst.
Dec 1, 2025
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Jun 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05383521
Lead sponsor
Shangrong Fan
Responsible party
Shangrong Fan (Profesor, Peking University Shenzhen Hospital) — Sponsor-investigator
First posted
May 20, 2022
Start date
Dec 1, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jun 11, 2024

Study contacts

Yiheng Liang, M.D.
Contact
13510331823@163.com
86-755-83923333 ext. 5518
Ping Liu, M.D.
Contact
253783006@qq.com
86-755-83923333 ext. 5505
Shangrong Fan Fan, M.D.
principal investigator · Peking University Shenzhen Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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