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The Effects of the Female Hormones on Cerebral Perfusion

U

University Ghent

Status

Enrolling

Conditions

Contraception
Menstrual Cycle
Cerebral Perfusion

Treatments

Device: Physiological monitoring
Biological: Blood sample
Diagnostic Test: Pregnancy test
Device: Body temperature
Device: MRI scan
Other: Questionnaires
Device: Blood pressure measurement

Study type

Observational

Funder types

Other

Identifiers

NCT03299179
EC/2016/0757

Details and patient eligibility

About

Measuring brain perfusion is biased by a inter- and intrasubject variability, caused by physiological and lifestyle factors. In this study, the investigators want to investigate the variations in cerebral perfusion and other brain parameters (grey matter, resting-state brain activity, brain connectivity and white matter diffusion) caused by the female sex hormones and hormonal contraception.

Enrollment

62 estimated patients

Sex

Female

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Bachelor or Master student
  • Minimum of 3 months not using contraception of using Deso20

Exclusion criteria

  • No informed consent
  • MRI-contraindications
  • Claustrophobia
  • Pregnancy or breastfeeding
  • Chronic diseases and chronic medication use
  • Smoker
  • Drug use
  • Abuse of alcohol and caffeine

Trial design

62 participants in 2 patient groups

Natural cycle
Description:
15 female volunteers, not using hormonal contraception, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 3 times: during the follicular phase, during ovulation and during luteal phase.
Treatment:
Device: Physiological monitoring
Biological: Blood sample
Other: Questionnaires
Device: MRI scan
Diagnostic Test: Pregnancy test
Device: Body temperature
Device: Blood pressure measurement
Anti-conception
Description:
15 female volunteers, using hormonal contraception pill Deso 20, will be scanned during 3 menstrual cycles. During each cycle, the volunteers will be scanned 2 times: during the pill-week and during the pill-free week.
Treatment:
Device: Physiological monitoring
Biological: Blood sample
Other: Questionnaires
Device: MRI scan
Device: Body temperature
Device: Blood pressure measurement

Trial contacts and locations

1

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Central trial contact

Patricia Clement, Msc

Data sourced from clinicaltrials.gov

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