In this study we look at how long it takes for the levels of certain hormones and hormone-binding proteins to normalize discontinuation of COC use, in particular corticosteroid-binding globulin.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
- No intervention
N.a.
Outcome measures
Primary outcome
<p>CBG en total cortisol concentrations</p>
Secondary outcome
<p>Secundary: VDBP -vitamin D; TBG - T4, T3; SHBG - testosterone; IGFBP3- IGF1.<br>Tertiairy: albumin, prolactin, fT3, fT4, TSH, estradiol, progesterone, LH, FSH.<br>HCG at last blood sampling.</p>
Background summary
Due to the increase in corticosteroid-binding globulin (CBG) and therefore total cortisol when using oral estrogens, oral estrogen-containing contraceptives (COC's) are discontinued during endocrine function tests that measure total cortisol. It's unclear how long after discontinuation of oral estrogens CBG and total cortisol
concentrations normalize.
Study objective
In this study we look at how long it takes for the levels of certain hormones and hormone-binding proteins to normalize discontinuation of COC use, in particular corticosteroid-binding globulin.
Study design
Weekly blood samples in the morning for a total of eight weeks: 2 weeks while taking the contraceptive pill and 6 weeks after discontinuation of the contraceptive pill. Additionally, participants will be asked about relevant
history / medication use and height and weight will be measured.
Intervention
N.a.
Study burden and risks
Burden consists mainly in the form of 8 visits to the Amsterdam UMC, AMC location, with 8 additional venipunctures. Venipunctures have very minor risks other than hematomas and discomfort.
A.C. Heijboer
Meibergdreef 9
Amsterdam 1105AZ
Netherlands
020-5666434
lab-endo@amsterdamumc.nl
A.C. Heijboer
Meibergdreef 9
Amsterdam 1105AZ
Netherlands
020-5666434
lab-endo@amsterdamumc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
=/> 18 years old, female, stopping combined oral contraceptive use for at least
6 weeks
Exclusion criteria
Switching to other hormonal contraceptives after taking COC's;
contra-indications to quit COCs;
biological factors that affect CBG concentrations (severe kidney/liver disease, active malignancy, hyperthyroidism); use of insulin, systemic glucocorticoids, mitotane, SERMs.
If patient gets pregnant during study period: exclusions of measurements after
pregnancy.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06802211 |
| CCMO | NL87932.018.24 |
| Research portal | NL-005395 |