Colposeptine for the Treatment of Bacterial Vaginosis

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

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 in various centers in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Co., Ltd., China
• Treatments: Chlorquinaldol; Metronidazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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