CBG Normalization After Discontinuation of COC's (NCT06802211) | Clinical Trial Compass
CompletedNot Applicable
CBG Normalization After Discontinuation of COC's
Netherlands24 participantsStarted 2025-02-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time to normalization of CBG and total cortisol concentrations
Timeframe: 8 weeks
Trial details
NCT IDNCT06802211
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)