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Trial record 26 of 55 for:    "Vaginitis" | "Metronidazole"

Colposeptine for the Treatment of Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT01153958
Recruitment Status : Terminated
First Posted : June 30, 2010
Results First Posted : August 21, 2012
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date  ICMJE June 28, 2010
First Posted Date  ICMJE June 30, 2010
Results First Submitted Date  ICMJE July 18, 2012
Results First Posted Date  ICMJE August 21, 2012
Last Update Posted Date February 13, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
Percentage of Participants With Relapse 2 Months Post-treatment [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
Relapse rate of Colposeptine and Metronidazole in the treatment of Bacterial Vaginosis. [ Time Frame: End of second month after treatment ]
Change History Complete list of historical versions of study NCT01153958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
  • Percentage of Participants With Relapse 1 Month Post-treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Relapse rate [ Time Frame: At the end of first month after treatment completion ]
  • Change of nugent score and lactobacilli number of vaginal discharge after treatment [ Time Frame: End of second month after treatment ]
  • Adverse effects, including nausea ,vomiting and local reaction [ Time Frame: Throughout the study (2 months) ]
  • Curative rate of Colposeptine and Metronidazole in the treatment of Bacterial Vaginosis. [ Time Frame: End of 1st week after treatment completion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colposeptine for the Treatment of Bacterial Vaginosis
Official Title  ICMJE The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vaginosis, Bacterial
Intervention  ICMJE
  • Drug: Colposeptine
    Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
    Other Name: Chlorquinaldol-Promestriene Vaginal Capsules
  • Drug: Metronidazole
    Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
Study Arms  ICMJE
  • Experimental: Colposeptine (A)
    Intervention: Drug: Colposeptine
  • Active Comparator: Metronidazole (B)
    Intervention: Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 14, 2012)
133
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2010)
480
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01153958
Other Study ID Numbers  ICMJE EMR200059-504
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor  ICMJE Merck KGaA, Darmstadt, Germany
Collaborators  ICMJE Merck Serono Co., Ltd., China
Investigators  ICMJE
Study Director: Study Director Merck Serono Co., Ltd., China
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP