EUCTR2006-004399-11-DE进行中（未招募）不适用
The Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Aerobic Bacterial Vaginal Infections in Comparison to Placebo
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medinova AG
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Postmenarchal women aged 18 to 55 years which have not yet reached menopause
- •2. Signs and symptoms of aerobic bacterial vaginal infections, corresponding to a Total Symptoms Score =5 (discharge, pruritus, and burning are added using a 4-point scale)
- •3. Disturbed vaginal microflora with Lactobacillary Grade III
- •4. Cultural proof of at least one of the associated bacteria,
- •i.e. streptococci, enterococci, S. aureus, pseudomonas, E. coli or other enterobacteria
- •5.Patients of child bearing potential must be using a highly effective form of birth control such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or have a vasectomized partner
- •6. Signed Written Informed Consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of Bacterial vaginosis and/or presence of clue cells
- •2. Diagnosis of vulvovaginal candidiasis based on clinical symptoms and/or microscopic examination of the vaginal smear
- •3. Pregnancy and lactation
- •4. Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
- •5. Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
- •6. Use of any vaginal medication in the previous 7 days
- •7. Use of vaginal douches, particularly containing soaps
- •and other anionic, surface-active substances, in the
- •previous 48 hours and/or during the entire duration of
- •8. Known or suspected hypersensitivity to one of the study medications, inclusive their excipients
- •9. Ulceration of the vulva, vagina or cervix (damaged vaginal surface)
- •10. Patients receiving systemic immunosuppressive therapy or who have immune system deficiency
- •11. Malignant tumours in the genital tract
- •12. Suspicion of or clinically manifest Sexually Transmitted Diseases (STDs), i.e: Neisseria gonorrhoea, Chlamydia trachomatis, Trichomonas vaginalis, Treponema
- •pallidum, Herpes simplex virus type 2, condylomata, human immunodeficiency viruses (HIV)
- •13. Acute infections of the upper genital tract
- •14. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study
- •15. Patient is relative of or staff directly reporting to the investigator
- •16. Patient is employee of the sponsor
研究者
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