Colposeptine for the Treatment of Bacterial Vaginosis

This study has been terminated.
Sponsor:
Collaborator:
Merck Serono Co., Ltd., China
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01153958
First received: June 28, 2010
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Vaginosis, Bacterial
Drug: Colposeptine
Drug: Metronidazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Colposeptine in Bacterial Vaginosis. A Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Percentage of Participants With Relapse 2 Months Post-treatment [ Time Frame: 2 months post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month post-treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 133
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Colposeptine (A) 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
Active Comparator: Metronidazole (B) Drug: Metronidazole
Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153958

Locations
China
Peking University People's Hospital
Beijing, China
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
Sponsors and Collaborators
Merck KGaA
Merck Serono Co., Ltd., China
Investigators
Study Director: Study Director Merck Serono Co., Ltd., China
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01153958     History of Changes
Other Study ID Numbers: EMR200059-504
Study First Received: June 28, 2010
Results First Received: July 18, 2012
Last Updated: January 20, 2014
Health Authority: China: Ethics Committee

Keywords provided by Merck KGaA:
Vaginosis, Bacterial
Colposeptine
Metronidazole

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Chlorquinaldol
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 16, 2014