Status:
UNKNOWN
The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Major Depressive Disorder
Sexual Behavior
Eligibility:
FEMALE
18-22 years
Phase:
NA
Brief Summary
Large register based work has shown that starting on oral contraceptives (OCs) is associated with an increased risk of developing depressive episodes. It is not known why this is, but changes in the s...
Detailed Description
Background: More than 100 million women worldwide use combined oral contraceptives (OCs), i.e. the most common types that combine estrogen and gestagen. Register-based epidemiological work has recent...
Eligibility Criteria
Inclusion
- Healthy women at 18-22 years of age
- No use of hormonal contraception within the last year
- Having a regular menstrual cycle of approximately 28 days, i.e., approximately 28 days between first day of menstrual bleedings.
Exclusion
- Current or previous neurological or psychiatric disease, severe somatic disease, or consumption of medical drugs likely to influence the test results
- Non-fluent in Danish or pronounced visual or auditory impairments
- Current or past learning disability
- Current or previous pregnancy
- A wish to become pregnant within the following 6 months
- Participation in experiments with exposure to radioactivity (\> 10 mSv) within the last year or significant occupational exposure to radioactivity
- Contraindications for MRI (pacemaker, metal implants, claustrophobia)
- Allergy to the ingredients in the administered drug
- A diagnosis of hypo- or hypertension
- A history of head injury or concussion resulting in loss of consciousness for more than 2 min
- Alcohol abuse
- Drug use other than tobacco and alcohol within the last 30 days
- Cannabis \> 50 x lifetime
- Recreational drugs \> 10 x lifetime (for each substance)
- Nicotine addiction
- Current psychoactive medication
- Any risk factors for thromboembolic events
- Other contraindications for use of Femicept
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05212389
Start Date
December 22 2021
End Date
August 31 2025
Last Update
February 28 2022
Active Locations (1)
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1
Neurobiology Research Unit
Copenhagen, Denmark, 2100