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NCT04278755 · ClinicalTrials.gov registry record · Phase 2
Binge Eating & Birth Control
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04278755: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT04278755 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278755, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.
Primary Outcome
Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention.
Interventions
- DRUG Drospirenone-Ethinyl Estradiol Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-09-24 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 2 |
Why NCT04278755 stopped before completion
NCT04278755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Drospirenone-Ethinyl Estradiol Oral Tablet is the first listed.
NCT04278755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04278755 about?
NCT04278755 is a clinical study titled "Binge Eating & Birth Control". This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for th...
What is the current status of trial NCT04278755?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2020-09-24. Estimated completion is 2022-05-17.
What interventions are being tested in trial NCT04278755?
The interventions under investigation include: Drospirenone-Ethinyl Estradiol Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04278755?
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 NCT04278755's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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