Trial · NCT04278755
Binge Eating & Birth Control
NCT04278755, Phase 2, Terminated, University of North Carolina, Chapel Hill; results first posted 2022-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Binge Eating & Birth Control. Trials, record NCT04278755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04278755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Binge Eating & Birth Control
- NCT number
- NCT04278755
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Bulimia Nervosa, Binge Eating, Eating Disorders, Binge-Eating Disorder
- Interventions
- Drospirenone-Ethinyl Estradiol Oral Tablet
- First posted
- 2020-02-20
- Last updated
- 2022-07-26
- Results first posted
- 2022-07-26
- Limitations and caveats
- The study was terminated early due to the inability to recruit eligible participants therefore only a very small number of participants have available data.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency | Pre-intervention (week 1) to intervention endpoint (week 12) | 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. |
| Primary | Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score | Pre-intervention (week 1) to intervention endpoint (week 12) | Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention. |
| Primary | Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment. |
| Primary | Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment. |
| Primary | Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment. |
| Primary | Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k | Pre-intervention (week 1) to intervention endpoint (week 12) | The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention. |
| Secondary | Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score | Pre-intervention (week 1) to intervention endpoint (week 12) | Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention. |
| Secondary | Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score | Pre-intervention (week 1) to intervention endpoint (week 12) | The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | episodes/week | MEAN |
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants who started the study medication and completed the pre-intervention and intervention endpoints | score on a scale | MEAN |
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable. | percentage signal change | MEAN |
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable. | percentage signal change | MEAN |
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants who started the study medication and completed the pre-intervention and intervention endpoints. Due to technological error when saving data, one participant's endpoint MRI data was unusable. | percentage signal change | MEAN |
| PRIMARY | Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | k value | MEAN |
| SECONDARY | Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | score on a scale | MEAN |
| SECONDARY | Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score | Pre-intervention (week 1) to intervention endpoint (week 12) | Participants that started the study medication and completed the pre-intervention and intervention endpoints. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency | Continuous OC | -0.43 | Standard Deviation 1.27 | episodes/week | |
| Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score | Continuous OC | -6.60 | Standard Deviation 7.11 | score on a scale | |
| Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Continuous OC | .0423 | Standard Deviation .26 | percentage signal change | |
| Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Continuous OC | Caudate | -.012 | Standard Deviation .11 | percentage signal change |
| Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Continuous OC | Putamen | .02 | Standard Deviation .10 | percentage signal change |
| Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT) | Continuous OC | .01 | Standard Deviation .15 | percentage signal change | |
| Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k | Continuous OC | .01 | Standard Deviation .013 | k value | |
| Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score | Continuous OC | 1.60 | Standard Deviation 2.30 | score on a scale | |
| Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score | Continuous OC | 1.43 | Standard Deviation 5.41 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Continuous OC | 8 | |
| Overall Study | COMPLETED | Continuous OC | 7 | |
| Overall Study | NOT COMPLETED | Continuous OC | 1 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Menstrual Bleeding | Reproductive system and breast disorders | Continuous OC | 4 | 8 | 7 |
| other | Bloating | Endocrine disorders | Continuous OC | 2 | 8 | 2 |
| other | Breast Tenderness | Reproductive system and breast disorders | Continuous OC | 2 | 8 | 2 |
| other | Nausea | Gastrointestinal disorders | Continuous OC | 2 | 8 | 2 |
| other | Cramps | Reproductive system and breast disorders | Continuous OC | 3 | 8 | 4 |
| other | Irritability | Psychiatric disorders | Continuous OC | 2 | 8 | 2 |
| other | Spotting | Reproductive system and breast disorders | Continuous OC | 8 | 8 | 14 |
| other | Lethargic | General disorders | Continuous OC | 1 | 8 | 1 |
| other | Anxiety | Psychiatric disorders | Continuous OC | 2 | 8 | 4 |
| other | Low Mood | Psychiatric disorders | Continuous OC | 1 | 8 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Continuous OC | 0 | 8 |
| Total, other adverse events | Continuous OC | 8 | 8 |
| Total, serious adverse events | Continuous OC | 0 | 8 |
Source ClinicalTrials.gov
Papers79
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delay Discounting | Primary outcome | ConductCognition |
| Monetary Incentive Delay | Primary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04278755
GET https://conductscience.org/api/trials/v1/NCT04278755/papers?page=2