At a glance
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Ovarian Hormones, Reward Response, and Binge Eating in Bulimia Nervosa: An Experimental Design
In Brief
A Phase 2 clinical trial evaluating Estradiol, Micronized progesterone, and 2 other interventions for Bulimia Nervosa. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This pilot study experimentally manipulates ovarian hormones to examine the direct impact of estrogen (E2) and progesterone (P4) on binge eating symptom burden and the behavioral reward response in women with bulimia nervosa (n=15). This is completed by taking medications that change ovarian hormone levels. This line of research could lead to the development of pharmacological interventions developed to target specific areas of the brain, brain receptors, or pathways identified to be involved in the mechanism underlying ovarian hormone change and binge eating.
Study Details
Timeline
Interventions
During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.