Binge Eating & Birth Control

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Foundation of Hope, North Carolina
• Treatments: Drospirenone; Drospirenone and ethinyl estradiol combination; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

Inclusion Criteria

Participants will include women ages 18-34 with a current Diagnostic and Statistical Manual (DSM-5) diagnosis of a binge eating syndrome and a regular menstrual cycle. Only participants capable of giving informed consent and understanding the risks associated with the study will be enrolled.

• Current binge eating behaviors meeting DSM-5 criteria for a binge eating syndrome

• Age 18-34

• Regular menstrual cycle for at least 3-months

• Free of medication or medical condition that impacts ovarian hormones or is contraindicated for use with study interventions (including birth control)

• Speaks English

Exclusion Criteria

• any foreign metal objects or implants in your body as determined by the safety questionnaires (due to fMRI)

• use of birth control or hormones in the past 3-months

• hormonal contraceptives that are implanted (i.e. progestin intrauterine device or implant)

• current pregnancy, lactation, or < 12-weeks postpartum

• previous serious, negative reaction to birth control

• current smoker

• < 18.5 BMI > 31

• history of bipolar disorder or psychotic episodes

• frequent laxative and/or diuretic use

• previous suicide attempt

• abnormal/undiagnosed vaginal bleeding; endometriosis

• recurrent migraine headaches or headaches with focal neurological symptoms

• hypertension or vascular disease (i.e., coronary artery disease, congestive heart failure, cerebrovascular disease)

• diabetes or other circulation problems

• blood clotting disorder

• porphyria

• breast, uterus/cervix, or vaginal cancer

• medical condition or medication use that increases serum potassium levels (including frequent laxative or diuretic use)

• high cholesterol

• history of venous thromboembolus (VTE), deep vein thrombosis, pulmonary embolism, phlebothrombosis, coronary thrombosis, thromboembolism, thrombophlebitis, or any type of blood clot or blood clot disorder (e.g., thromboembolic disease, Factor V Leiden), protein C or S deficiency, heart attack or stroke, atrial fibrillation, heart, liver, kidney, or adrenal disease, endocarditis, liver cancer, malignant melanoma, cholecystitis or pancreatitis, VTE or jaundice caused by pregnancy or birth control pills, recent significant period of immobility (e.g., pregnancy bed rest), immediate family history of a hereditary blood clotting disorder

• Pregnant women will be excluded from participation and women who become pregnant (although unlikely) will be withdrawn. Prior to enrollment, a pregnancy test will be completed. All participants will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study. If a woman becomes pregnant during the study, participation will be discontinued.

• Any condition or symptoms considered by the study team to detrimentally impact subject safety.