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

NCT05383521 | Not Yet Recruiting

• 1 other identifier: 2020PUSZH001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Conditions

Trichomonas Vaginitis

Keywords

Refractory Trichomonas Vaginitis; Tinidazole

Outcome Measures

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.

  24 weeks

Secondary Outcomes (1)

• Safety of tinidazole tablets

  24 weeks

Study Arms (2)

Tinidazole 56

EXPERIMENTAL

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

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.

Drug: Tinidazole 56

Interventions

Tinidazole 56 DRUG

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

Tinidazole 42

Tinidazole 42 DRUG

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

Tinidazole 56

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Allergy to metronidazole or tinidazol
• Pregnant or nursing
• HIV or other chronic disease

Sponsors & Collaborators

• Shangrong Fan: lead

Study Sites (4)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

Location

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, China

Location

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

MeSH Terms

Conditions

Trichomonas Vaginitis

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shangrong Fan Fan, M.D.

  Peking University Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiheng Liang, M.D.

CONTACT

86-755-83923333; 13510331823@163.com

Ping Liu, M.D.

CONTACT

86-755-83923333; 253783006@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Profesor

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: May 20, 2022
• Study Start: December 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (4)