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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01153958
Other study ID # EMR200059-504
Secondary ID
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


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
See also
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