Clinical trial NCT01153958: Colposeptine for the Treatment of Bacterial Vaginosis
Official title: The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vaginosis, Bacterial
Keywords: Vaginosis, Bacterial
Colposeptine
Metronidazole
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2010-06-30
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in various centers in China.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Relapse 2 Months Post-treatment
timeFrame: 2 months post-treatment
Secondary outcomes:
measure: Percentage of Participants With Relapse 1 Month Post-treatment
timeFrame: 1 month post-treatment
measure: Change From Baseline in Nugent Score at 2 Months Post-treatment
timeFrame: Baseline and Month 2 post-treatment
measure: Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
timeFrame: Baseline and Month 2 post-treatment
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 2 months post-treatment
measure: Percentage of Participants Cured
timeFrame: 1 week post-treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chengdu
country: China
facility: Second Hospital of West China Medical School, Sichuan University
city: Shanghai
country: China
facility: Obstetrics & Gynaecology Hospital of Fudan University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
Study officials:
affiliation: Merck Serono Co., Ltd., China
name: Study Director
role: STUDY_DIRECTOR
References: