Colposeptine for the Treatment of Bacterial Vaginosis

Study Overview
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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.

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

Conditions
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Vaginosis, Bacterial

Intervention / Treatment
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* Drug: Colposeptine
* Drug: Metronidazole


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colposeptine (A)<br> | Drug: Colposeptine<br>* Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days<br>* Other names: Chlorquinaldol-Promestriene Vaginal Capsules;|
| Active Comparator: Metronidazole (B)<br> | Drug: Metronidazole<br>* Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginosis, Bacterial, Colposeptine, Metronidazole