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NCT05388656 · ClinicalTrials.gov registry record · Phase 4
Estrogen Variability and Irritability During the Menopause Transition
A Phase 4 study of Menopause and Irritable Mood, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05388656: Completed Phase 4 study of Menopause and Irritable Mood, sponsored by University of North Carolina, Chapel Hill.
NCT05388656 is a Phase 4 study of Menopause and Irritable Mood that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 40 participants, below the 9,393-participant average among 54 other Menopause trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05388656, a Phase 4 study of Menopause and Irritable Mood, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.
Primary Outcome
The 5-item ill temper scale of the Inventory of Depression and Anxiety Symptoms (IDAS) will be the primary measure of irritability symptom severity. Each symptom item is rated 1 (not at all) to 5 (extremely). The total IDAS ill temper scale score may range from 5-25. Higher scores indicate more severe irritability symptoms. The average daily irritability scores will be evaluated for each 3-week treatment condition (Active Estradiol vs. Placebo).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release
- DRUG Progesterone 200 mg
Study Locations (1)
North Carolina
- Carolina Crossing B, Suite 1 - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-06-15 |
| Est. Completion | 2025-01-17 |
| Phase | Phase 4 |
What the finished NCT05388656 record still lists
NCT05388656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 9,393-participant average among 54 other Menopause trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Menopause appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05388656 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05388656 about?
NCT05388656 is a clinical study titled "Estrogen Variability and Irritability During the Menopause Transition". Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimen...
What is the current status of trial NCT05388656?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2022-06-15. Estimated completion is 2025-01-17.
What conditions does trial NCT05388656 study?
This clinical trial studies the following conditions: Menopause, Irritable Mood.
What interventions are being tested in trial NCT05388656?
The interventions under investigation include: Placebo (DRUG), Estradiol Patch, 0.1 mg/24 Hours Weekly Transdermal Film, Extended Release (DRUG), Progesterone 200 mg (DRUG).
Who is sponsoring clinical trial NCT05388656?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05388656 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05388656's enrollment target sits among peer trials
40 37th of 54 higher than 16 of 54 other Menopause trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Menopause trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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