Primary objective: to investigate whether HPA-axis responses during the ACTH (Synacthen) stimulation are differentially influenced by distinct hormonal contraceptives, as compared to responses measured during the natural menstrual cycle (luteal…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde vrouwen met hormonale anticonceptiegebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum levels of estradiol, progesterone, cortisol, FSH and LH at baseline and
in response to the Synacthen test.
Basal serum cortisol binding globulin (CBG) and ACTH levels.
DNA for genotyping functional SNPs. Genotyping will be performed in
glucocorticoid receptor (GR) in order to control for genetic changes.
Saliva levels of free cortisol at baseline and in response to the Synacthen
test.
Secondary outcome
Basal cortisol levels as measured in hair strands; Heart rate measurements
Background summary
In order to avoid interpretation problems relating to the impact of hormonal
steroids on HPA-axis variables, research on the hormonal or cardiovascular
responses to stress frequently excludes women who use hormonal contraceptives,
or simply women overall.
Despite the worldwide usage of modern hormonal contraceptive methods, there is
a scarcity of data available exploring the effects of hormonal contraception on
hormone responses to different stressors. In particular, data on the impact of
progestins on HPA-axis functioning in humans is rare and the mechanism needs to
be clarified.
Study objective
Primary objective: to investigate whether HPA-axis responses during the ACTH
(Synacthen) stimulation are differentially influenced by distinct hormonal
contraceptives, as compared to responses measured during the natural menstrual
cycle (luteal phase) in healthy women.
Secondary objective: to examine chronic HPA-axis functioning over a 3-month
period using hair samples in order to determine if the distinct contraceptive
methods influence cumulative cortisol levels, compared to the natural menstrual
cycle (lutheal phase) in healthy women.
Study design
In this observational cross-sectional study, we will administer the ACTH
stimulation (Synacthen) test in healthy female subjects using either a combined
estrogen/progesterone hormonal contraceptive, a progesterone-only preparation
or in women with a natural menstrual cycle.
Healthy female subjects using the ethinylestradiol/levonorgestrel products as
oral combined contraceptives, monophasic contraceptives, sub-50, formulation 30
µg ethinylestradiol / 15 µg levonorgestrel, (market names: Microgynon30,
Marvelon, Stediril30) or progesterone-only will be included in the study.
Intervention
The low-dose ACTH 1µg (Synacthen) stimulation test will be administered to all
study participants.
Study burden and risks
The low dose (1mcgr) ACTH (Synacthen) stimulation test will be perfomed by all
the female participants. No side effects were reported. The total of 50ml blood
will be drawn through IV. 5 samples saliva will be collected; 1 lock hair will
be cut from the scalp. In total the procedure will take about 2,5 hours.
's gravendijkwal 230
Rotterdam 3015 CE
NL
's gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Healthy female participants using either a hormonal contraceptive combined method (Microgynon30, Stediril30, Marvelon) or a progesterone-only method (Mirena)
Exclusion criteria
Female subjects with a history of psychiatric illness and/or psychotherapeutic treatments; drug abuse; neurological, cardiovascular or respiratory diseases, allergies, asthma; pregnancy or lactation.
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 |
|---|---|
| EudraCT | EUCTR2012-005640-14-NL |
| CCMO | NL42994.078.13 |