Colposeptine for the Treatment of Bacterial Vaginosis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Vaginosis, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colposeptine (A)

Group Type EXPERIMENTAL

Colposeptine

Intervention Type DRUG

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

Metronidazole (B)

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

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

Interventions

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Colposeptine

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

Intervention Type DRUG

Metronidazole

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

Intervention Type DRUG

Other Intervention Names

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Chlorquinaldol-Promestriene Vaginal Capsules

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No