Skip to content

A multi-center randomized sigle-blind parallel active controll trial to evaluate the efficacy and safety of Ornidazole Vaginal Gel on Bacterial vaginosis

A multi-center randomized sigle-blind parallel active controll trial to evaluate the efficacy and safety of Ornidazole Vaginal Gel on Bacterial vaginosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000616
Enrollment
Unknown
Registered
2009-11-29
Start date
2009-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis

Interventions

Control group:Ornidazole Vaginal Suppository 0.5g, Vaginal medication, qd, 5 days
test group:Ornidazole Vaginal Gel 0.5g, Vaginal medication, q.d, 5 days

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients in accordance with bacterial vaginosis diagnostic standards; 2. Patients have sexual life and not in menses. Age: 20-55; 3. Patients with good follow-up and compliance conditions and should sign the Informed Consent Form; 4. Menstrual laws,away from the next menstrual flow at least 7 days.

Exclusion criteria

Exclusion criteria: 1. The patients have other reproductive tract infections, such as trichomonas vaginitis, vulvovaginal vaginosis; 2. Patients allergy to nitroimidazoles and any other two or more drugs; 3. Pregnant and lactating women; 4. Patients have heart, liver, kidney, hematopoietic and endocrine system diseases; 5. Abnormal laboratory test results show clinical significance: (1) A LT and AST are 3 times more than normal value; (2) WBC<3.6*10^9/L; (3) PLT<70*10^9/L; (4) Abnormality of electrocardiogram has clinical significance; (5) BUN and Cr are greater than normal value; 6. Psychopath and the patients that can not cooperate for other reasons; 7. Patients participated other clinical trials during last 3 months; 8. Patients have used any vaginal local drug during the last one week; 9. Patients with alcohol and drug abuse experience; 10. Patients used system antibiotics at the same time; 11. Any other unsuitable reasons for the trial.

Design outcomes

Primary

MeasureTime frame
Efficacy on bacteria examinations (3-7 days after treatment);Comprehensive efficacy (3-7 days after the treatme);

Secondary

MeasureTime frame
Clinical efficacy (28±2 days after the treatment);Efficacy on bacteria examinations (28±2 days after treatment);Comprehensive efficacy (28±2 days after the treatm);Clinical efficacy (3-7 days after the treatment);

Countries

China

Contacts

Public ContactLina Hu, Hongwei Liu
cqhulina@126.com+86 028 58803776,

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026