Colposeptine for the Treatment of Bacterial Vaginosis

The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study

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.

Study Overview

• Status: Terminated
• Conditions: Vaginosis, Bacterial
• Intervention / Treatment: Drug: Colposeptine; Drug: Metronidazole

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital
  • Chengdu, China
    • Second Hospital of West China Medical School, Sichuan University
  • Shanghai, China
    • Obstetrics & Gynaecology Hospital of Fudan University
  • Shenzhen, China
    • Peking University Shenzhen Hospital
  • Wuhan, China
    • Wuhan Union Hospital of China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colposeptine (A)	Drug: Colposeptine; Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days; Other Names: Chlorquinaldol-Promestriene Vaginal Capsules
Active Comparator: Metronidazole (B)	Drug: Metronidazole; Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Relapse 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.	2 months post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Relapse 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.	1 month post-treatment
Change From Baseline in Nugent Score at 2 Months 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.	Baseline and Month 2 post-treatment
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months 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.	Baseline and Month 2 post-treatment
Number of Participants With Adverse Events (AEs)	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.	Up to 2 months post-treatment
Percentage of Participants Cured	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.	1 week post-treatment

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborators: Merck Serono Co., Ltd., China
• Investigators: Study Director: Study Director, Merck Serono Co., Ltd., China

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): February 13, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Metronidazole; Vaginosis, Bacterial; Colposeptine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Chlorquinaldol
• Other Study ID Numbers: EMR200059-504