Colposeptine for the Treatment of Bacterial Vaginosis

NCT01153958 | Terminated Phase 4 Results

• 1 other identifier: EMR200059-504
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 5

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.

Conditions

Vaginosis, Bacterial

Keywords

Vaginosis, Bacterial; Colposeptine; Metronidazole

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Participants With Relapse 1 Month Post-treatment

  1 month post-treatment

• Change From Baseline in Nugent Score at 2 Months Post-treatment

  Baseline and Month 2 post-treatment

• Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment

  Baseline and Month 2 post-treatment

• Number of Participants With Adverse Events (AEs)

  Up to 2 months post-treatment

• Percentage of Participants Cured

  1 week post-treatment

Study Arms (2)

Colposeptine (A)

EXPERIMENTAL

Drug: Colposeptine

Metronidazole (B)

ACTIVE COMPARATOR

Drug: Metronidazole

Interventions

Colposeptine DRUG

Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days

Also known as: Chlorquinaldol-Promestriene Vaginal Capsules

Colposeptine (A)

Metronidazole DRUG

Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days

Metronidazole (B)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Co., Ltd., China: collaborator

Study Sites (5)

Peking University People's Hospital

Beijing, China

Location

Second Hospital of West China Medical School, Sichuan University

Chengdu, China

Location

Obstetrics & Gynaecology Hospital of Fudan University

Shanghai, China

Location

Peking University Shenzhen Hospital

Shenzhen, China

Location

Wuhan Union Hospital of China

Wuhan, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Study Director

  Merck Serono Co., Ltd., China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 13, 2014
• Results First Posted: August 21, 2012

Record last verified: 2014-01

Locations

CN (5)