Girls and women 14 years - 35 years, considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs MedDRA version: 21.1 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10010808 Term: Contraception System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 22.0 Level: PT Classification code 10073728 Term: Hormonal contraception Sys
Conditions
Interventions
Trade Name: Selina Gynial
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ETHINYLESTRADIOL
CAS Number: 57-63-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Universität Salzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Girls and women 14 years - 35 years, 2. considering the intake of COCs or under current use of EE/LNG or EE/CMA COCs, with a 3. regular menstrual cycle for at least 6 months according to the criteria of Fehring et al. (2006) and 4. sufficient German language skills to follow task instructions Are the trial subjects under 18? yes Number of subjects for this age range: 350 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Known contra-indication to use of EE/LNG or EE/CMA COCs, 2. diagnosed psychiatric disorder with known effects on cognition or brain structure/function (e.g. schizophrenia, etc.) with the exception of mood disorders 3. diagnosed neurological disorder with known effects on cognition or brain structure/function (e.g. multiple sclerosis, epilepsy, etc.) 4. diagnosed endocrinological disorder deemed clinically significant by the Investigator at screening (e.g. PCOS, Cushing's syndrome, congenital renal hyperplasia) 5. regular intake of medication that might interfere with the conduct of the study or the interpretation of the results (defined below) 6. current pregnancy or previous pregnancies 7. for MR group: contra-indication for MRI 8. for MR group: brain tissue abnormalities on structural MRI as screened by a neuro-radiologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Drug trial on neurocognitive off-target effects of contraceptive drugs;Secondary Objective: A secondary objective is to identify predictors of cognitive, emotional and neuronal off target effects of oral contraceptives, among: -Brain imaging parameters -Steroid hormone levels -Genes related to steroid hormone action and neurotransmission ;Primary end point(s): Cognitive, emotional and neuronal off target effects of COC treatment (maximum change from study visit 1 and timepoint of maximum Change);Timepoint(s) of evaluation of this end point: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Predictors of cognitive, emotional and neuronal off target effects of COC treatment, including - brain imaging parameters - steroid hormone levels - genes related to steroid actions or neurotransmissio ;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Austria
Contacts
Public ContactBelinda Pletzer
Universität Salzburg
Outcome results
None listed