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临床试验/NCT06802211
NCT06802211已完成不适用

The Effect of Discontinuing Estrogen Containing Oral Contraceptives on Corticosteroid-binding Globulin and Total Cortisol Concentrations

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Time to normalization of CBG and total cortisol concentrations

研究概览

简要总结

In this study, the investigators aim to examine after which duration corticosteroid-binding globulin (CBG) and total cortisol concentrations return to normal after cessation of the combined oral contraceptive pill in healthy women.

详细描述

Use of exogenous estrogens is known to increase corticosteroid-binding globulin (CBG) levels and thereby total cortisol concentrations measured in serum. When endocrine function are performed to assess hypothalamus-pituitary-adrenal function, total cortisol levels are measured in serum. When women use exogenous oral estrogen, for instance the birth control pill, the current recommendation is to discontinue oral estrogens for at least 6 weeks before the test. This may introduce diagnostic delay and inconvenience for the patient. The duration it takes for CBG concentrations to return to normal, have not been studied in vivo as far as known by the investigators.

The main objective of this prospective observational study is to determine the duration in which CBG and total cortisol concentrations return to normal after cessation of oral estrogen. Secondary objectives are to examine the normalization of other hormone binding proteins and their corresponding hormones (VDBP & vitamin D; TBG & T4, T3; SHBG & testosterone; IGFBP3 & IGF1).

The study population consists of healthy women aged ≥18 years old, who are planning to stop using combined oral contraceptives (COCs) for at least six weeks. The study consists of 8 weekly blood samples. The first blood sample will be performed one week before cessation of COCs, the second one at the moment of cessation and after cessation the next six weekly blood samples will be taken.

After establishing when values return to normal, doctors have a better idea of how many weeks after stopping COCs, blood results can be properly assessed. If the duration were shorter than six weeks, this would mean less inconvenience for women undergoing dynamic function tests who would have to stop taking their contraceptive pill.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •≥18 years old
  • •Using oral combined contraceptives of any kind and dosage
  • •Planning to stop COC use shortly for at least 6 weeks (out of own reasons such as a pregnancy wish or choice for non-hormone based contraceptives)
  • •COC use for at least 3 consecutive weeks before the discontinuation
  • •Ability to provide informed consent
  • •Ability to speak and understand Dutch

排除标准

  • •Switching to other hormonal contraceptives after taking the COC pill (e.g. progesterone containing contraceptives such as the Mirena IUD, contraceptive implants) directly after the discontinuations
  • •Contra-indications to quit COC
  • •Biological factors that affect CBG concentrations, including:
  • •Illnesses interfering with CBG levels (severe liver or kidney disease, active malignancy, hyperthyroidism)
  • •Use of insulin, systemic exogenous glucocorticoids, mitotane, selective estrogen receptor modulators (SERMs)
  • •Pregnancy during study period after discontinuation of COCs

结局指标

主要结局

Time to normalization of CBG and total cortisol concentrations

时间窗: 8 weeks

Time in weeks until plateau is reached.

次要结局

  • Time to normalization of VDBP, vitamin D, TBG, T4, T3, SHBG, testosterone, IGFBP3 and IGF1(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annemieke Heijboer

Prof. Dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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