Status:
TERMINATED
Binge Eating & Birth Control
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Foundation of Hope, North Carolina
Conditions:
Bulimia Nervosa
Binge Eating
Eligibility:
FEMALE
18-34 years
Phase:
PHASE2
Brief 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 b...
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 understo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04278755
Start Date
September 24 2020
End Date
May 17 2022
Last Update
July 26 2022
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599