NCT00397670已完成2 期
A Multicenter Open-Label Study of the Safety and Contraceptive Efficacy of BufferGel® Spermicide Used With Diaphragm
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Contraceptive efficacy (pregnancy rate) at six months (183 days).
研究概览
简要总结
The purpose of this study is to study the safety and contraceptive effectiveness of BufferGel used with a contraceptive diaphragm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •be healthy women, who are sexually active, at risk for pregnancy and desiring contraception
- •be within the age range of 18 through 40 years inclusive
- •be at low-risk for human immunodeficiency virus (HIV) or sexually transmitted disease (STD) infection, currently have (≥4 months) a single sexual partner who is also at low-risk for HIV or STD infection and expect to have the same partner for the duration of the study
- •have a negative urine pregnancy test at the admission visit
- •have normal cyclic menses with a usual length of 24 to 35 days over the last 2 months
- •have a documented history of at least one spontaneous, normal menstrual cycle (two menses) since delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy
- •be willing to accept a risk of pregnancy
- •be willing to engage in at least 4 acts of heterosexual vaginal intercourse per cycle for a period of approximately seven months
- •be willing to be randomized to either study treatment as applicable
- •be willing to be fitted with a diaphragm and use the diaphragm with test product during all acts of heterosexual vaginal intercourse for the duration of the study
- •be willing to only use the test product with diaphragm as the primary method of contraception over the course of the study [with the exception of emergency contraception pills (ECPs), when indicated]
- •be capable of using the product and diaphragm properly and agree to observe all study directions and requirements
排除标准
- •have a history of allergy or sensitivity to spermicides, products containing N-9, and/or products containing latex
- •have a history of toxic shock syndrome
- •have had two or more UTIs in the past year or currently have a suspected or diagnosed UTI or vaginitis by dipstick urinalysis or wet mount, unless treated and proof of cure is documented
- •be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study
- •have a history of infertility or conditions which may lead to infertility
- •have contraindications to pregnancy (medical condition) or chronic use of class D or X medications
- •have been hospitalized for pelvic inflammatory disease without a subsequent intrauterine pregnancy
- •have had more than one sexual partner in the past 4 months
- •have shared injection drug needles within the past 6 months
- •have, or suspected to have, HIV infection
- •have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within the 3 months prior to screening, or have clinical evidence of HSV on exam
- •have been diagnosed with any other STDs (including trichomonas) in the 6 months prior to the screening visit
- •be lactating or breastfeeding have had a Depo-Provera injection in the 10 months prior to screening
- •have a vaginal or cervical abnormality that would interfere with the proper placement and retention of test product and diaphragm
- •In addition, in order to be eligible to participate in the trial, potential subjects must state that, to her best knowledge, her sexual partner meets the following criteria:
- •is not infertile
- •has not been treated for Chlamydia trachomatis or N. gonorrhoeae in the past 6 months
- •has not been previously diagnosed with, or suspected to have, HIV infection
- •has not had more than one sexual partner in the past 4 months
- •has not engaged in homosexual intercourse in the past 10 years
- •has not shared injection drug needles in the past 10 years
- •has no history of allergy or sensitivity to spermicides or products containing N-9
- •has no history of allergy or sensitivity to products containing latex
结局指标
主要结局
Contraceptive efficacy (pregnancy rate) at six months (183 days).
次要结局
未报告次要终点
研究者
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