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Completed

NCT Number: NCT06802211

CBG Normalization After Discontinuation of COC's

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Time to normalization of CBG and total cortisol concentrations

    Time frame: 8 weeks

    Time in weeks until plateau is reached.

Secondary outcomes

  1. Time to normalization of VDBP, vitamin D, TBG, T4, T3, SHBG, testosterone, IGFBP3 and IGF1

    Time frame: 8 weeks

    Time in weeks until plateau is reached.

Other outcomes

  1. Estradiol concentration

    Time frame: 8 weeks

    Used for determining menstrual cycle

  2. Progesterone concentration

    Time frame: 8 weeks

    Used for determining menstrual cycle

  3. LH concentration

    Time frame: 8 weeks

    Used for determining menstrual cycle

  4. FSH concentration

    Time frame: 8 weeks

    Used for determining menstrual cycle

  5. Occurrence of vaginal blood loss

    Time frame: 8 weeks

    Used for determining menstrual cycle

  6. Albumin concentration

    Time frame: 8 weeks

  7. Prolactin concentration

    Time frame: 8 weeks

  8. fT3 and fT4 concentration

    Time frame: 8 weeks

  9. TSH concentration

    Time frame: 8 weeks

  10. HCG concentration

    Time frame: Measured at 6th week after cessation of COCs

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.