CBG Normalization After Discontinuation of COC's

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how long it takes for certain hormone levels, specifically corticosteroid-binding globulin (CBG) and cortisol, to return to normal after stopping the use of combined oral contraceptives (COCs). The researchers want to help understand the effects of stopping these birth control pills, which many women use for various reasons, including planning for a pregnancy or wanting to switch to non-hormonal methods.

To participate in this study, women aged 18 and older who have been using any type of combined oral contraceptives for at least three weeks and are planning to stop for at least six weeks can apply. However, women who switch to other hormonal contraceptives right after stopping the COCs or have certain health conditions that could affect hormone levels will not be eligible. If you join the trial, you’ll be helping researchers learn more about how stopping these pills affects hormone levels, which could benefit many women in the future.

Gender

FEMALE

Eligibility criteria

• 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