healthy female volunteers
Conditions
Interventions
Trade Name: Synacthen 0,25 mg/ml
Pharmaceutical Form: Injection
Trade Name: Ethinylestradiol/levonorgestrel 0,03/0,15 mg
Pharmaceutical Form: Tablet
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy female participants using either a hormonal contraceptive combined method (Microgynon30, Stediril30, Marvelon) or a progesterone-only method (Mirena) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether HPA-axis responses during an ACTH stimulation (Synacthen) test differ as a function of hormonal contraceptive method used, as compared to responses measured during the natural menstrual cycle (luteal phase) in healthy women. ;Secondary Objective: to assess a basal HPA-axis functioning over a period of several months using hair samples in order to determine if the contraceptive method used has an effect on tonic cortisol levels as compared to the natural menstrual cycle in healthy women. ;Primary end point(s): - The levels of ACHT, cortisol, cortisol binding globuline (CBG), progesterone, and estradiol in serum. - The levels of free cortisol in saliva before and during a Synacthen test. ;Timepoint(s) of evaluation of this end point: The levels of ACTH, cortisol, CBG, progesterone, estradiol in serum, levels of salivary cortisol will be measured just before the injection and at the three time point after synacthen injection every 30 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Basal cortisol levels as measured in hair strands;Timepoint(s) of evaluation of this end point: Basal cortisol levels in hair strands will be evaluated once. | — |
Countries
Netherlands
Contacts
Public Contacttrial information
Erasmus MC
Outcome results
None listed