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NCT03003949 · ClinicalTrials.gov registry record · Phase 4
The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT03003949: Clinical Trial Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT03003949 is a Phase 4 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03003949, a Phase 4 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this research is to understand the mechanisms by which variability in estradiol (E2) is associated with the symptoms of anxiety and anhedonia (loss of interest and pleasure - a common symptom of depression). By stabilizing E2 variability with a hormonal manipulation, this research will determine the degree to which the E2 variability (or E2 levels) plays a causal role in perimenopausal anxiety and anhedonia symptoms and whether it does so by affecting biological responses to stress.
Primary Outcome
The State-Trait anxiety inventory is consists of 20 questions on a 4-point force-choice Likert-type response scales (scores 0 - 3). The 20 questions are summed together for final score. The score can range from 0 to 60 with higher scores representing higher levels of anxiety. Change over time is defined as the difference in the least square means between timepoints and 95% confidence interval limits.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Placebo Patch
- DRUG Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release
- DRUG Progesterone Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2017-01-24 |
| Est. Completion | 2020-05-10 |
| Phase | Phase 4 |
Why NCT03003949 stopped before completion
NCT03003949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Oral Capsule is the first listed.
NCT03003949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03003949 about?
NCT03003949 is a clinical study titled "The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood". Women in the menopause transition ('perimenopause') are exposed to extreme hormone variability, tend to experience a unique set of severe stressors (e.g., divorce, death of loved ones), and are also at substantially elevated risk to suffer from mood and anxiety disorders. The purpose of this researc...
What is the current status of trial NCT03003949?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2017-01-24. Estimated completion is 2020-05-10.
What interventions are being tested in trial NCT03003949?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Placebo Patch (DRUG), Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release (DRUG), Progesterone Capsule (DRUG).
Who is sponsoring clinical trial NCT03003949?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03003949's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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