drugset / Trial / NCT03172533

Estrogen Replacement in Anorexia Nervosa

NCT03172533

Phase 2 Terminated 11 enrolled University of Erlangen-Nürnberg Medical School
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The present study is a placebo-controlled randomised study on the effects of estrogen replacement upon AN-associated psychopathology, several neurocognitive domains and appetite-regulating circuits in female patients with AN. The investigators aim at assessing peripheral concentrations of neuroendocrinological components of the Hypothalamus-Pituitary-Gonadal (HPG) and Hypothalamus-Pituitary-Adrenal (HPA) axis, as well as appetite-regulating hormones in AN and to examine associations with AN-associated psychopathology and neurocognitive performances before (baseline), during and after inpatient psychotherapy of female patients receiving concomitant treatment with estrogens (vs. placebo).

Timeline

Start
2016-03-15
Primary completion
2019-01-15
Completion
2019-01-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dienogest Small molecule 2 mg Oral
Comparator ethinyl estradiol Small molecule 0.03 mg Oral

Indications