Colposeptine for the Treatment of Bacterial Vaginosis

Vaginosis, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01153958
• Other study ID #: EMR200059-504
• Status: Terminated
• Phase: Phase 4
• First received: June 28, 2010
• Last updated: January 20, 2014
• Start date: July 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Colposeptine
Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
• Metronidazole
Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Co., Ltd., China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No