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Colposeptine for the Treatment of Bacterial Vaginosis

NCT01153958 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2014-02-13

Study results available
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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

Interventions

DRUG

Colposeptine

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

DRUG

Metronidazole

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

Sponsors & Collaborators

  • Merck Serono Co., Ltd., China

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Study Director · Merck Serono Co., Ltd., China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01153958 on ClinicalTrials.gov