Colposeptine for the Treatment of Bacterial Vaginosis
- Registration Number
- NCT01153958
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 133
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colposeptine (A) Colposeptine - Metronidazole (B) Metronidazole -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Relapse 2 Months Post-treatment 2 months post-treatment Relapse: recurrence of the symptoms of bacterial vaginosis \[BV\] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Relapse 1 Month Post-treatment 1 month post-treatment Relapse: recurrence of the symptoms of bacterial vaginosis \[BV\] (Nugent score greater than or equal to 7, symptoms of vaginal irritation for example, pain, burning, odour or abnormal vaginal discharge) after a period of improvement. Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated BV.
Change From Baseline in Nugent Score at 2 Months Post-treatment Baseline and Month 2 post-treatment Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicate bacterial vaginosis.
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment Baseline and Month 2 post-treatment The grades of Lactobacilli in vaginal discharge were Grade 1 (Normal): Lactobacillus morphotypes predominate; Grade 2 (Intermediate): Mixed flora with some Lactobacilli present, but Gardnerella or Mobiluncus morphotypes also present; Grade 3 (Bacterial Vaginosis): Predominantly Gardnerella and/or Mobiluncus morphotypes, few or absent Lactobacilli.
Number of Participants With Adverse Events (AEs) Up to 2 months post-treatment An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Percentage of Participants Cured 1 week post-treatment Cure was defined as Nugent score less than 7, no symptoms of vaginal irritation (for example, pain, burning, odour or abnormal vaginal discharge). Nugent score was calculated by assessing for presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0-4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0-4), and curved Gram-variable rods (Mobiluncus species morphotypes; scored as 0-2). Total score range: 0-10. Score of 7-10 indicated bacterial vaginosis.
Trial Locations
- Locations (5)
Second Hospital of West China Medical School, Sichuan University
🇨🇳Chengdu, China
Obstetrics & Gynaecology Hospital of Fudan University
🇨🇳Shanghai, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, China
Wuhan Union Hospital of China
🇨🇳Wuhan, China
Peking University People's Hospital
🇨🇳Beijing, China