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NCT04051320 · ClinicalTrials.gov registry record · Phase 2
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT04051320 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 23 participants.
The verdict
NCT04051320, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.
Interventions
- DRUG Micronized progesterone
- DRUG Leuprolide Acetate 3.75 MG/ML
- DRUG Estradiol 2 Mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-01-02 |
| Est. Completion | 2022-07-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04051320
The ClinicalTrials.gov registry entry for NCT04051320 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Micronized progesterone is the first listed.
NCT04051320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04051320 about?
NCT04051320 is a clinical study titled "Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model". The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritab...
What is the current status of trial NCT04051320?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-01-02. Estimated completion is 2022-07-19.
What interventions are being tested in trial NCT04051320?
The interventions under investigation include: Micronized progesterone (DRUG), Leuprolide Acetate 3.75 MG/ML (DRUG), Estradiol 2 Mg tablet (DRUG).
Who is sponsoring clinical trial NCT04051320?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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