In this study we look at how long it takes for the levels of certain hormones and hormone-binding proteins to normalizediscontinuation of COC use, in particular corticosteroid-binding globulin.
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
CBG en total cortisol concentrations
Secondary outcome
Secundary: VDBP -vitamin D; TBG - T4, T3; SHBG - testosterone; IGFBP3- IGF1.
Tertiairy: albumin, prolactin, fT3, fT4, TSH, estradiol, progesterone, LH, FSH.
HCG at first blood sampling
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.
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.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
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
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 |
|---|---|
| CCMO | NL87932.018.24 |