Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of… (NCT04330677) | Clinical Trial Compass
CompletedPhase 1
Dissecting the Role of Estradiol in Mediating Gender-specific Anxiolytic and Prosocial Effects of Oxytocin
Germany487 participantsStarted 2016-09-18
Plain-language summary
The study aims to examine a behavioral and neural framework for understanding the sex-specific effects of the neuropeptide oxytocin (OXT). Using hormonal, behavioral and neuroimaging readouts, it is planned to explore the interplay of OXT and estradiol as a potential mechanism mediating sexual dimorphic effects.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* right handed
* healthy male \& female volunteers
* women will be tested in their follicular phase (Day 0-5)
Exclusion Criteria:
* smoking
* pregnancy
* hormonal contraception
* current psychiatric illness
* current psychiatric medication or psychotherapy
* Study 2: MRI contraindication (e.g. metal in body, claustrophobia)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Electrodermal responses to fear-conditioned stimuli
Timeframe: 3 hours after gel administration and 30 minutes after nasal spray administration
2
Emotion recognition thresholds
Timeframe: 200 minutes after gel administration and 50 minutes after nasal spray administration
3
Resting state functional connectivity
Timeframe: 3 hours after gel administration and 30 minutes after nasal spray administration
4
Neural responses to emotional faces
Timeframe: 190 minutes gel administration and 40 minutes after nasal spray administration
5
Neural responses to an emotional subsequent memory task
Timeframe: 200 minutes after gel administration and 50 minutes after nasal spray administration