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NCT03172533: HOSAN

Estrogen Replacement in Anorexia Nervosa

Terminated Phase 2 Last updated 30 January 2019
What this trial tests

Phase 2 trial testing ethinyl estradiol 0.03mg and dienogest 2 mg (combination) in Anorexia Nervosa in 11 participants. Terminated before completion.

Timeline
15 March 2016
Primary endpoint
15 January 2019
15 January 2019

Quick facts

Lead sponsorUniversity of Erlangen-Nürnberg Medical School
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment11
Start date15 March 2016
Primary completion15 January 2019
Estimated completion15 January 2019
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

Adults 18 to 45, female only, with Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prospective, randomized, double-blind, placebo-controlled phase IIa clinical trial on the effects of an estrogen-progestin combination as add-on to inpatient psychotherapy in adult female patients suffering from anorexia nervosa.
    Paslakis G, Maas S, Gebhardt B, Mayr A, et al · · 2018 · cited 5× · PMID 29631553 · DOI 10.1186/s12888-018-1683-1

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Other recruiting trials for Anorexia Nervosa

Currently open trials in the same condition.

Other University of Erlangen-Nürnberg Medical School trials

Trials by the same sponsor.

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