Status:
TERMINATED
Colposeptine for the Treatment of Bacterial Vaginosis
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Co., Ltd., China
Conditions:
Vaginosis, Bacterial
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled ...
Eligibility Criteria
Inclusion
- Female subjects in reproductive age and older than 18 year
- Subjects with normal sexual activity
- Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
- Subjects with Nugent Score greater than or equal to 7
- Subjects who are willing to use contraception
- Subjects who are willing to refrain from the use of other vaginal products throughout the study
- Subjects who sign informed consent form and agree to follow-up on time
Exclusion
- Subjects without sexual activity
- Pregnant or lactating female subjects
- Subjects with a history of recurrent bacterial vaginosis
- Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
- Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
- Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole)
- Subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion
- Female subjects with a history of peripheral neuropathy
- Female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
- Subjects who are unable to give written informed consent
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01153958
Start Date
July 1 2010
End Date
November 1 2010
Last Update
February 13 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, China
2
Second Hospital of West China Medical School, Sichuan University
Chengdu, China
3
Obstetrics & Gynaecology Hospital of Fudan University
Shanghai, China
4
Peking University Shenzhen Hospital
Shenzhen, China