Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive
研究概览
简要总结
The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •15-25 years of age (inclusive)
- •History of regular menstrual cycle
- •Not pregnant
- •No plan to become pregnant in the next 3 months
- •Interested in beginning use of OC, DMPA, or LNG-IUD
- •Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)
排除标准
- •Anticipated move out of area that prevents return for a follow-up visit
- •Unavailability for follow-up visit
- •Less than 90 days post-partum or post-abortion
- •Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
- •Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
- •DMPA injection less than 6 months prior to enrollment
- •History of immunosuppressive condition of current use of immunosuppressive medications
- •History of a cervical malignancy
- •Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
- •Intolerance or contradiction to use of OC, DMPA, or LNG-IUD
研究组 & 干预措施
Depo-Provera
Women who choose to initiate Depo-Provera
干预措施: Depo-Provera (Drug)
Mirena
Women who choose to initiate Mirena (intrauterine device)
干预措施: Mirena (Drug)
Oral contraception
Women who choose to initiate oral contraception
干预措施: Oral contraception (Drug)
结局指标
主要结局
Proliferative capacity (i.e., ability to respond to antigen stimulation) of T cells isolated from the cervix of women before and after initiating a hormonal contraceptive
时间窗: Prior to and ~ 1 month (but up to 2 months) after initiation of a hormonal contraceptive
次要结局
未报告次要终点
研究者
Thomas Cherpes, DVM, MD
Associate Professor
Ohio State University