Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
研究概览
简要总结
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal.
- •Currently taking or want to start oral contraceptives for contraception
- •Non-smoker.
- •Competent to give informed consent (as judged by the investigator).
- •Provided written informed consent.
- •Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).
排除标准
- •Abnormal breast examination.
- •History or current therapeutic or prophylactic use of anticoagulants.
- •Known bleeding disorder or history of unexplained bleeding or bruising.
- •History of breast cancer or previous diagnostic breast biopsy.
- •Known allergy to local anesthetic.
- •Currently pregnant or pregnant within the previous 6 months.
- •Having any standard contra-indication to being prescribed OCs.
研究组 & 干预措施
Ortho-Novum® 1/35
Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
干预措施: Oral Contraceptive: Ortho-Novum® 1/35 (Drug)
Ovcon Fe®
Ovcon Fe® is an oral contraceptive that contains less progestin.
干预措施: Oral Contraceptive: Ovcon Fe® (Drug)
结局指标
主要结局
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups
时间窗: 32 weeks
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
次要结局
未报告次要终点