Colposeptine for the Treatment of Bacterial Vaginosis

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 4

Conditions

Vaginosis, Bacterial

Treatments

Drug: Colposeptine

Drug: Metronidazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01153958

EMR200059-504

Details and patient eligibility

About

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.

Enrollment

133 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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