CBG Normalization After Discontinuation of COC's

NCT06802211 | Completed

• 1 other identifier: NL87932.018.24
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Combined Oral Contraceptive Cessation

Keywords

CBG; corticosteroid-binding globulin; total cortisol; combined oral contraceptives; COCs

Outcome Measures

Primary Outcomes (1)

• Time to normalization of CBG and total cortisol concentrations

  Time in weeks until plateau is reached.

  8 weeks

Secondary Outcomes (1)

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

  8 weeks

Other Outcomes (10)

• Estradiol concentration

  8 weeks

• Progesterone concentration

  8 weeks

• LH concentration

  8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult females who are planning to discontinue estrogen containing oral contraceptives for a duration of at least 6 weeks.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples

Study Officials

• Annemieke C Heijboer, Prof. Dr.

  Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Laboratory Medicine, Endocrine Laboratory, Boelelaan 1117, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 31, 2025
• Study Start: February 5, 2025
• Primary Completion: November 18, 2025
• Study Completion: November 18, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)