COLPOSEPTINE (18 TABLETS)

769911188

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Promestriene

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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.

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.

  • 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,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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

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