The Effects of the Female Hormones on Cerebral Perfusion

December 5, 2023 updated by: University Ghent

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

30 healthy young volunteers, either using no hormonal anti-conception, either using Deso20 as anti-conception.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Natural cycle
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.
Device: MRI scan
Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).
Device: Physiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Biological: Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Device: Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Device: Body temperature
Measuring body temperature before and after MRI-scan
Other: Questionnaires
Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)
Diagnostic test: Pregnancy test
Test for pregnancy using a pregnancy dipstick test
Anti-conception
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.
Device: MRI scan
Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).
Device: Physiological monitoring
During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
Biological: Blood sample
Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
Device: Blood pressure measurement
Measuring blood pressure before and after MRI-scan
Device: Body temperature
Measuring body temperature before and after MRI-scan
Other: Questionnaires
Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
measured during scan-session
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
measured during scan-session
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
measured during scan-session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional grey matter volume (mm³): natural versus contraception
Time Frame: measured during scan-session
Differences in regional grey matter volume between volunteers of the natural cycle group versus the volunteers using contraception
measured during scan-session
Regional grey matter volume (mm³) variations during natural menstrual cycle
Time Frame: measured during scan-session
Variations during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measured during scan-session
Regional grey matter volume (mm³) variations during menstrual cycle using contraception
Time Frame: measured during scan-session
Variations in grey matter volume during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measured during scan-session
Resting state brain activity: natural versus contraception
Time Frame: measured during scan-session
Differences in resting state brain activity between volunteers of the natural cycle group versus the volunteers using contraception
measured during scan-session
Resting state brain activity variations during natural menstrual cycle
Time Frame: measured during scan-session
Variations in resting state brain activity during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measured during scan-session
Resting state brain activity variations during menstrual cycle using contraception
Time Frame: measured during scan-session
Variations in resting state brain activity during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measured during scan-session
Cerebral diffusion properties: natural versus contraception
Time Frame: measured during scan-session
Differences in diffusion properties (Mean Diffusivity(MD)/Apparent Diffusion Coefficient (ADC)/fractional Anisotropy(FA)) between volunteers of the natural cycle group versus the volunteers using contraception
measured during scan-session
Cerebral diffusion properties variations during natural menstrual cycle
Time Frame: measured during scan-session
Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: follicular phase versus ovulation versus luteal phase in the natural cycle group, correlated with female hormones measured in blood sample
measured during scan-session
Cerebral diffusion properties variations during menstrual cycle using contraception
Time Frame: measured during scan-session
Variations in diffusion properties (MD/ADC/FA) during the menstrual cycle: pill-week versus pill-free week in the contraception group, correlated with female hormones measured in blood sample
measured during scan-session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Achten, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC/2016/0757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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