The Effects of Dose and Formulation of Oral Contraceptives (OCs) on Breast-Cell Proliferation: Can the Chemopreventive Effects of OCs on Endometrial and Ovarian Cancer be Extended to Breast Cancer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Breast Cell Proliferation Levels Between the Three Oral Contraceptive 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 estrogen (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 estrogen; 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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI <30 kg/m2
- •Premenopausal with regular cycles or currently taking an OC
- •Not currently or recently pregnant or nursing (within previous 6 months)
- •No use of antibiotics within the prior 4 weeks
- •Competent to provide written informed consent (as judged by study team)
- •Willing to adhere to the OC regimen
- •Willingness to refrain from the use of aspirin or NSAIDS 10 days pior to the biopsy appointment and one week following the biopsy procedure
- •Willing and able to refrain from use of fish oils 10 days prior to the biopsy appointment and one week following the biopsy procedure
排除标准
- •Abnormal breast examination
- •Abnormal PT/INR and/or CBC with platelets test results (as determined by one of the study physicians)
- •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
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® 35
Ovcon® 35 is an oral contraceptive that contains less progestin.
干预措施: Oral Contraceptive: Ovcon® 35 (Drug)
Microgestin Fe® 1/20
is an oral contraceptive that contains less estrogen.
干预措施: Oral Contraceptive: Microgestin Fe® 1/20 (Drug)
结局指标
主要结局
Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups
时间窗: Up to 3 months.
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