ISRCTN16203579已完成2 期
Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a randomised controlled trial among Chinese women
Shanghai Institute of Planned Parenthood Research (China)0 个研究点目标入组 200 人开始时间: 2008年5月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
- 2012 results in https://www.ncbi.nlm.nih.gov/pubmed/23089047 (added 28/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Eligibility requirements included:
- •1. Sexually active female
- •2. Aged 20 - 45 years old
- •3. Presumably fertile based on at least one delivery record
- •4. At risk for pregnancy and desiring contraception
- •5. Having regular menstrual cycle (21 - 35 days) and at least three normal menstrual cycles since the last pregnancy, abortion or hormone contraceptive use
- •6. Be willing to engage in at least four acts of sexual intercourse per month
- •7. Use the test products as their primary method of contraception
- •8. Keep a diary of coital activity, product use, and adverse events
- •9. At low risk for human immunodeficiency virus (HIV) or other sexually transmitted infection, which was defined as having a single sexual partner (for at least six months prior to study initiation)
- •10. The subject's sexual partner should not be presumably infertile, have a known allergy to BZK or N-9, or have been treated for sexually transmitted diseases (STDs) within six months prior to study entry
排除标准
- •Exclusion criteria included:
- •1. Diagnosis of any vaginal infection or any symptom of STDs at baseline
- •2. Known allergy or hypersensitivity to N-9 or BZK
- •3. Menopause for more than one month
- •4. Breastfeeding
- •5. Vaginal bleeding with unknown reasons
- •6. Recurrent vaginitis or urinary infection
- •7. Genitourinary system anomaly
- •8. Hysteroptosis II or severe cystocele
- •9. Moderate to severe erosion of cervix
- •10. Malignant reproductive system tumours
研究者
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