The Hormonal contraception and the HPA-axis

Active, not recruiting

Conditions: healthy female volunteers
hormonal contraception method used: combined method (oestrogens en progestins) and progesterone-only method.
MedDRA version: 14.1Level: HLTClassification code 10010812Term: Contraceptive methods femaleSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2012-005640-14-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

Female subjects with a history of psychiatric illness and/or psychotherapeutic treatments; drug abuse; neurological, cardiovascular or respiratory diseases, allergies, asthma; pregnancy or lactation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- The levels of free cortisol in saliva before and during a Synacthen test.<br><br>;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.<br>

Secondary Outcome Measures

Name	Time	Method
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.