1. Examen if the outcome of the 1 mg Overnight Dexamethasone suppression test is influenced by the use of oral contraception.2. Examen how many weeks after ceasing the use of orale contraception the 1 mg Overnight Dexamethason suppression test is…
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum cortisol after the 1 mg overnight dexamethasone suppression test during
use of OAC and after one and six weeks of ceasing of contraception.
Urinary and salivary cortisol during use of OAC and after one and six weeks of
ceasing of contraception.
Secondary outcome
If necessary: CBG, ACTH, free cortisol, FSH, LH
Background summary
The use of oral contraceptives possibly influences the outcome of the 1 mg
Overnight Dexamethasone suppression test.
The 1 mg Overnight Dexamethasone suppression test is a frequently used
diagnostic test to exclude hypercortisolism. 1mg dexamethason is given at 23:00
and the serum cortisol is measured the morning after at 08:00h. Oral
contraception increases protein boudning of cortisol, as a result a falsely
elevated serum cortisol may be measured. Oral contraception are used
frequently. As a result of this, the interpretation of the 1 mg Overnight
Dexamethasone suppression test isoften hindered in clinical practice. The
literature is unambiguous about the inter pretation of the 1 mg Overnight
Dexamethasone suppression test when oral contraception is used. Advised is to
withdraw oral contraception before doing the 1 mg Overnight Dexamethasone
suppression test. There is no consensus about the duration of withdrawing of
oral contraception.
This study aims to determine if there is a differende in the serum cortisol
with and without use of oral contraception and if so, how long the use of oral
contraception should be withdrawn to exclude this influence
Study objective
1. Examen if the outcome of the 1 mg Overnight Dexamethasone suppression test
is influenced by the use of oral contraception.
2. Examen how many weeks after ceasing the use of orale contraception the 1 mg
Overnight Dexamethason suppression test is normalized.
3. Examen if urinary and salivary cortisol are good alternatives for the
screening on hypercorticism during use of contraception.
Study design
Intervention study: cross over trial
Intervention
Performing the 1 mg Overnight Dexamethasone suppression test at the end of the
third week of oral contraception. Afterwards the use of oral contraception is
ceased and is the 1 mg Overnight Dexamethason suppression test repeated at the
end of successively the first, and sixth week after ceasing oral contraceptive.
Also, urinary and salivary cortisol are collected three times for measurement
of cortisol
Study burden and risks
- Ceasing orale contrapceptives, consequently if no use of other
contraceptives: risk of pregnancy
- Risk of the 1 mg Overnight Dexamethasone suppression test. When 1 mg
Dexamethasone is taken once there are no adverse reactions expected
- 3x venepuncture and once urinary pregnancy test
- 4 visits to the hospital
Postbus 169
7000 AD Doentinchem
NL
Postbus 169
7000 AD Doentinchem
NL
Listed location countries
Age
Inclusion criteria
use of oral contraception
Exclusion criteria
Cushing's syndrome, psychiatric diseases, alcohol use of more than 7 units/week, pregnancy, steroid medication
Design
Recruitment
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 | NL31515.091.11 |