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Clinical Trials/NCT03299179
NCT03299179
Recruiting
Not Applicable

The Effects of the Female Sex Hormones and Hormonal Contraception on Cerebral Perfusion

University Ghent1 site in 1 country62 target enrollmentOctober 3, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Perfusion
Sponsor
University Ghent
Enrollment
62
Locations
1
Primary Endpoint
Regional cerebral perfusion (ml/100g/min): natural versus contraception
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2016
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Abuse of alcohol and caffeine

Outcomes

Primary Outcomes

Regional cerebral perfusion (ml/100g/min): natural versus contraception

Time Frame: measured during scan-session

Differences in regional perfusion between volunteers of the natural cycle group versus the volunteers using contraception

Regional cerebral perfusion (ml/100g/min) variations during natural menstrual cycle

Time Frame: measured during scan-session

Variations in cerebral perfusion during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample

Regional cerebral perfusion (ml/100g/min) variations during menstrual cycle using contraception

Time Frame: measured during scan-session

Variations in cerebral perfusion during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample

Secondary Outcomes

  • Regional grey matter volume (mm³): natural versus contraception(measured during scan-session)
  • Resting state brain activity variations during natural menstrual cycle(measured during scan-session)
  • Resting state brain activity: natural versus contraception(measured during scan-session)
  • Cerebral diffusion properties: natural versus contraception(measured during scan-session)
  • Cerebral diffusion properties variations during menstrual cycle using contraception(measured during scan-session)
  • Resting state brain activity variations during menstrual cycle using contraception(measured during scan-session)
  • Regional grey matter volume (mm³) variations during natural menstrual cycle(measured during scan-session)
  • Regional grey matter volume (mm³) variations during menstrual cycle using contraception(measured during scan-session)
  • Cerebral diffusion properties variations during natural menstrual cycle(measured during scan-session)

Study Sites (1)

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