Combined Oral Contraceptive CessationNCT06802211
CBG Normalization After Discontinuation of COC's
An observational study of Combined Oral Contraceptive Cessation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Combined Oral Contraceptive Cessation
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2025to 18 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Adult females who are planning to discontinue estrogen containing oral contraceptives for a duration of at least 6 weeks.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Discontinuing Estrogen Containing Oral Contraceptives on Corticosteroid-binding Globulin and Total Cortisol Concentrations
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.
Read the detailed description
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.
- Conditions
- Combined Oral Contraceptive Cessation
- Keywords
- CBG, corticosteroid-binding globulin, total cortisol, combined oral contraceptives, COCs
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to normalization of CBG and total cortisol concentrations
Time in weeks until plateau is reached.
Measured: 8 weeks
Secondary outcomes (1)
Time to normalization of VDBP, vitamin D, TBG, T4, T3, SHBG, testosterone, IGFBP3 and IGF1
Time in weeks until plateau is reached.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start5 Feb 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Oral Contraceptive CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annemieke Heijboer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Annemieke C Heijboer, Prof. Dr., Principal investigator, Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, Boelelaan 1117, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802211
- Sponsor's protocol ID
- NL87932.018.24
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Discontinuing Estrogen Containing Oral Contraceptives on Corticosteroid-binding Globulin and Total Cortisol Concentrations
- ClinicalTrials.gov ID
- NCT06802211
- Acronym / sponsor ID
- NL87932.018.24
- Conditions
- Combined Oral Contraceptive Cessation
- Keywords
- CBG, corticosteroid-binding globulin, total cortisol, combined oral contraceptives, COCs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult females who are planning to discontinue estrogen containing oral contraceptives for a duration of at least 6 weeks.
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to normalization of CBG and total cortisol concentrations
Time frame: 8 weeks
Time in weeks until plateau is reached.
1 secondary outcome
Time to normalization of VDBP, vitamin D, TBG, T4, T3, SHBG, testosterone, IGFBP3 and IGF1
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemieke C Heijboer, Prof. Dr. principal investigator
Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, Boelelaan 1117, Amsterdam, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Oral Contraceptive Cessation, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to normalization of CBG and total cortisol concentrations (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.