NCT04278755

Binge Eating & Birth Control

A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eating disorders (EDs) affect 15 million women in the United States and have one of the highest mortality rates of any mental illness. Despite this, the underlying neurobiology remains poorly understood. EDs predominantly occur in women, and the frequency of certain symptoms change in a predictable pattern over the menstrual cycle; specifically, symptom changes appear to be triggered by normal fluctuations in the ovarian hormones estradiol (E2) and progesterone (P4). The objective of this study is to examine the impact of ovarian hormone stabilization, through the continuous administration of oral contraceptives (OCs) for 3-months, on brain activation in response to reward and eating behaviors in women who binge eat (n=15) using functional magnetic resonance imaging (fMRI) and behavioral testing. OCs work by suppressing ovulation, thereby reducing E2 and P4 changes that occur pre- and post- ovulation. Because the traditional 21/7 regimen of OC administration (21 active pills followed by 7 days of inactive pills) allows follicles to begin to develop, this leads to the secretion of endogenous E2, and then E2 withdrawal once active pills begin again. This does not result in consistent stabilization. Thus, this study will use OCs in a continuous manner, with no inactive pills. Participants will complete fMRI imaging and self-report questionnaires prior to OC administration and at the end of OC administration. The investigators will examine within-subject changes that occur in these measures with OC administration. The primary hypothesis is that continuous OC treatment will have a beneficial/stabilizing effect on outcomes of interest. Specifically, symptomatology may decrease from OC use. Results will ultimately provide the pilot data necessary for larger mechanistic trials. The specific aims are to: Aim 1: Quantify the effect of ovarian hormone stabilization on eating behaviors in women with binge eating. Aim 2: Examine the effect of ovarian hormone stabilization on response to reward using fMRI and self-report questionnaires in women with binge eating.

Conditions

• Bulimia Nervosa
• Binge Eating
• Eating Disorders
• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Drospirenone-Ethinyl Estradiol Oral Tablet	3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.

Timeline

• Start date: 2020-09-24
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2020-02-20
• Last updated: 2022-07-26
• Results posted: 2022-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study