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Colposeptine for the Treatment of Bacterial Vaginosis

Primary Purpose

Vaginosis, Bacterial

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Colposeptine
Metronidazole
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginosis, Bacterial focused on measuring Vaginosis, Bacterial, Colposeptine, Metronidazole

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colposeptine (A)

Metronidazole (B)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 28, 2010
Last Updated
January 20, 2014
Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China
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1. Study Identification

Unique Protocol Identification Number
NCT01153958
Brief Title
Colposeptine for the Treatment of Bacterial Vaginosis
Official Title
The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Co., Ltd., China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Bacterial
Keywords
Vaginosis, Bacterial, Colposeptine, Metronidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colposeptine (A)
Arm Type
Experimental
Arm Title
Metronidazole (B)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Colposeptine
Other Intervention Name(s)
Chlorquinaldol-Promestriene Vaginal Capsules
Intervention Description
Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
Primary Outcome Measure Information:
Title
Percentage of Participants With Relapse 2 Months Post-treatment
Description
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.
Time Frame
2 months post-treatment
Secondary Outcome Measure Information:
Title
Percentage of Participants With Relapse 1 Month Post-treatment
Description
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.
Time Frame
1 month post-treatment
Title
Change From Baseline in Nugent Score at 2 Months Post-treatment
Description
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.
Time Frame
Baseline and Month 2 post-treatment
Title
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
Description
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.
Time Frame
Baseline and Month 2 post-treatment
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 2 months post-treatment
Title
Percentage of Participants Cured
Description
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.
Time Frame
1 week post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Merck Serono Co., Ltd., China
Official's Role
Study Director
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
Second Hospital of West China Medical School, Sichuan University
City
Chengdu
Country
China
Facility Name
Obstetrics & Gynaecology Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
Country
China
Facility Name
Wuhan Union Hospital of China
City
Wuhan
Country
China

12. IPD Sharing Statement

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Colposeptine for the Treatment of Bacterial Vaginosis

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