EUCTR2006-004398-89-DE进行中（未招募）不适用
Comparative Study of the Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Bacterial Vaginosis
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
- 500
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. Diagnosis of bacterial vaginosis (all 4 Amsel criteria must be positive)
- •3. 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 – excluded are methods that involve materials sensitive to mineral oil, like condoms, diaphragms
- •4. Signed Written Informed Consent to participate in this study
- •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. Pregnancy or lactation
- •2. Uterine bleeding (including menstruation but not
- •including cervical contact bleeding on sampling) or
- •vaginal bleeding of unknown origin
- •3. Acute infections of the upper genital tract
- •4. Clinical Symptoms of a vulvovaginal Candidiasis
- •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, or Lincomycin
- •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,
- •Trichomonas vaginalis, Treponema pallidum, Herpes
- •simplex virus type 2, condylomata, human
- •immunodeficiency viruses (HIV)
- •13. Participation of patient in another investigational drug
- •study concomitantly or within 30 days prior to entry in
- •14. Parallel use of Erythromycin
- •15. Regional enteritis, ulcerative colitis or medical history of
- •antibiotics-induced colitis
- •16. Patient is relatives of, or staff directly reporting to, the
- •investigator
- •17. Patient is employee of the sponsor
研究者
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