Colposeptine 18 Vaginal Tablets Merck Sharp & Dohme

Colposeptine 18 Vaginal Tablets Merck Sharp & Dohme

Brand:MSD Pharmaceuticals
Product Code:189
Availability:In Stock

Colposeptine uses and description Sort by popularity Colposeptine - Indications: vaginal disorders Indications: leucorrhoea Indications: colpitis, gonorrhoea Active ingredients: Chlorquinaldol/Promestriene Unit description, dosage Price, USD Tablet; Vaginal; Chlorquinaldol 200 mg; Promestriene 10 mg Colposeptine 18's Colposeptine 3 Blister x 6 Tablet.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Primary Completion Date: November 2010

Interventions Used in this Clinical Trial

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
Arms, Groups and Cohorts in this Clinical Trial

Experimental: Colposeptine (A)
Active Comparator: Metronidazole (B)
Outcome Measures for this Clinical Trial

Primary Measures
Percentage of Participants With Relapse 2 Months Post-treatment
Time Frame: 2 months post-treatment
Safety Issue?: No
Secondary Measures
Percentage of Participants With Relapse 1 Month Post-treatment
Time Frame: 1 month post-treatment
Safety Issue?: No
Change From Baseline in Nugent Score at 2 Months Post-treatment
Time Frame: Baseline and Month 2 post-treatment
Safety Issue?: No
Change From Baseline in Number of Participants With Each Grade of Lactobacilli at 2 Months Post-treatment
Time Frame: Baseline and Month 2 post-treatment
Safety Issue?: No
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 2 months post-treatment
Safety Issue?: Yes
Percentage of Participants Cured
Time Frame: 1 week post-treatment
Safety Issue?: No
Criteria for Participation in this Clinical Trial

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´╝îvulvovaginal candidiasis´╝îchlamydia 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
Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

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