NCT00692952已完成2 期
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Shanghai Institute of Planned Parenthood Research3 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- contraceptive efficacy
研究概览
简要总结
A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).
详细描述
A phase II, multicentric,randomized, controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at risk for pregnancy and desiring contraception
- •having regular menstrual cycle (21-35 days)
- •at low risk for HIV or other sexually transmitted infection
- •sexually active
- •use the test products as their primary method of contraception
- •keep a diary of coital activity, product use, and adverse events
排除标准
- •diagnosis of any vaginal infection or any symptom of STDs at baseline
- •known allergy or hypersensitivity to N-9 or BZK
- •menopause for more than one month
- •breastfeeding
- •vaginal bleeding with unknown reasons
- •genitourinary system anomaly
- •hysteroptosis II or severe cystocele
- •moderate to severe erosion of cervix
- •malignant reproductive system tumors
研究组 & 干预措施
1
Experimental
120 subjects using BenZalkonium Chloride Contraceptive Gel
干预措施: a novel Benzalkonium Chloride (BZK) contraceptive gel (Drug)
2
Active Comparator
120 subjects using Nonoxynol-9 contraceptive gel
干预措施: LELEMI® contraceptive gel containing 50mg nonoxynol-9 (Drug)
结局指标
主要结局
contraceptive efficacy
时间窗: March 2004 - November 2005
次要结局
- acceptability(March 2004 - November 2005)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a multicentric randomised controlled trialISRCTN16203579Shanghai Institute of Planned Parenthood Research (China)200
Unknown
4 期
An Efficacy Study of BCS Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPDChronic Obstructive Pulmonary DiseaseNCT02269800Lustre Pharmaceutical Lab Co., Ltd60
已完成
3 期
Multicenter Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal WomenVulvovaginal AtrophyNCT01816139Warner Chilcott576
已完成
2 期
Dose Ranging Study of SPL7013 Gel for Treatment of Bacterial Vaginosis (BV)Bacterial VaginosisNCT01201057Starpharma Pty Ltd132
已完成
3 期
Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal GelContraceptionNCT01306331Evofem Inc.3,389