NCT00399685已完成1 期
Study to Evaluate the Effect of Efavirenz Coadministration on the Pharmacokinetics of the Active Moieties of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
研究概览
简要总结
The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
- •Documented acceptable Pap smear within 1 year of the start of the study
- •BMI of 18-32 kg/m²
排除标准
- •Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
- •History of conditions in which oral contraceptives are contraindicated
- •History of migraine with focal aura
- •History of uncontrolled hypertension
- •Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
- •History of diagnosed mental illness or suicidal ideation
研究组 & 干预措施
A
Active Comparator
干预措施: Ortho Tri-Cyclen LO (Drug)
B
Active Comparator
干预措施: Ortho Cyclen (Drug)
C
Active Comparator
干预措施: Ortho Cyclen + Efavirenz (Drug)
D
Active Comparator
干预措施: Ortho Cyclen (Drug)
结局指标
主要结局
To determine the effect coadministration of efavirenz 600 mg on the pharmacokinetics of ethinyl estradiol and the metabolite of norgestimate
时间窗: throughout the study
次要结局
- Characterize the pharmacokinetics of efavirenz coadministered with the oral contraceptive Ortho Cyclen(throughout the study)
- Assess the effect of efavirenz coadministered with Ortho Cyclen on serum progesterone levels(throughout the study)
- Assess the safety of efavirenz coadministered with Ortho Cyclen(throughout the study)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy FemalesHIV InfectionsNCT00357604Bristol-Myers Squibb22
Unknown
4 期
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning ScalesPostpartum Depressive MoodPostpartum Sexual FunctionNCT02210702The Jones Institute33
终止
3 期
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)ContraceptionNCT02616146Organon and Co2,016
终止
3 期
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring in Women at Risk for Pregnancy (MK-8342B-061)ContraceptionNCT02524288Organon and Co1,941
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural RepairDura DefectsNCT01174992Ethicon, Inc.139