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Estrogen Replacement in Anorexia Nervosa (HOSAN)

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ClinicalTrials.gov Identifier: NCT03172533
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief 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).


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Drug: ethinyl estradiol 0.03mg and dienogest 2 mg (combination) Drug: Placebo oral capsule Phase 2

Detailed Description:

While there is broad knowledge on the disruption of appetite regulation, neurocognitive deficits in AN patients, the impact of cortisol on neurocognitive performances in patients with AN and the effects of estrogen on neurocognitive features in healthy subjects, up to now, no study has implemented estrogen replacement in AN patients, in order to examine ist effects upon AN-associated psychopathology, neurocognition and peptides regulating appetite. Thus, this is the first study of its kind.

Primary target: Assessment of the impact of sexual hormone replacement using an estrogen-progestin-combination as add-on to psychotherapy upon neurocognitive performance in patients suffering from anorexia nervosa by means of a neuropsychological test battery consisting of a test of verbal intelligence, the Trail making test A and B, a Go/No-go paradigm and the Wisconsin Card Sorting Test.

Secondary targets:

  • Examination of safety and tolerability of sexual hormone replacement using an estrogen-progestin-combination in patients with anorexia nervosa.
  • Assessment of the impact of the sexual hormone replacement upon psychopathology in patients with anorexia nervosa by means of the Eating Disorder Examination Questionnaire (EDE-Q) and the Eating Disorder Inventory-2 (EDI-2).
  • Assessment of the impact of substitution upon anxiety (STAI)
  • Assessment of the impact on cortisol levels
  • Assessment of the impact on appetite-regulating plasma peptides
  • Assessment of the impact on the prescription of antidepressants

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, placebo-controlled Phase IIa clinical trial in patients with anorexia nervosa
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blinded study
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Effects of an Estrogen-progestin Combination as add-on to Inpatient Psychotherapy in Adult Female Patients Suffering From Anorexia Nervosa
Actual Study Start Date : March 15, 2016
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: verum group
approved oral contraceptive: ethinyl estradiol 0.03mg and dienogest 2mg (combination drug) daily intake over 10 weeks
Drug: ethinyl estradiol 0.03mg and dienogest 2 mg (combination)
approved oral contraceptive (Germany): Maxim

Placebo Comparator: placebo group
placebo
Drug: Placebo oral capsule
placebo




Primary Outcome Measures :
  1. Changes in neurocognitive performance [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Performance based on a neurocognitive test battery


Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse Events (AE) (safety/tolerability) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Number of adverse events (including AE, AR, severe AE, SAR and SUSAR)

  2. Changes in psychopathology (EDE-Q) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in sum scores in the EDE-Q

  3. Changes in psychopathology (EDI-2) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in sum scores in the EDI-2

  4. Changes in psychopathology (STAI) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in sum scores in the STAI

  5. Changes in psychopathology (Patient Health Questionnaire-9, PHQ-9) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in sum scores in the PHQ-9

  6. Changes in psychopathology (Eating Disorder Quality of Life, EDQoL) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in sum scores in the EDQoL

  7. Neuroendocrinological changes (cortisol) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in plasma cortisol levels during a dexamethasone suppression test

  8. Neuroendocrinological changes (glucose) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in plasma concentrations of glucose

  9. Neuroendocrinological changes (insulin) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in plasma concentrations of insulin

  10. Neuroendocrinological changes (ghrelin) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in plasma concentrations of the appetite-regulating peptide ghrelin

  11. Neuroendocrinological changes (leptin) [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in plasma concentrations of the appetite-regulating peptide leptin

  12. Changes in antidepressant medication [ Time Frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination ]
    Changes in antidepressants´ use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • anorexia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) or subsyndromal anorexia nervosa (lack of a diagnostic symptom according to DSM V)
  • BMI ≥ 13 kg/m2 and ≤ 18.5 kg/m2
  • able to provide written informed consent

Exclusion Criteria:

  • a known hypersensitivity to the active compound or to other components of the study drug
  • one or more contraindications for the use of hormonal contraception: Smoking over 20 cigarettes/day; Acute venous thromboembolic disease or increased risk; Known hereditary or acquired predisposition for venous thrombosis, e.g. activated protein C (APC)-resistance (including factor V Leiden Mutation), antithrombin III deficiency, protein C deficiency, protein S deficiency; Risk for arterial thromboembolism (diabetes mellitus with vascular sequelae, severe hypertonus, severe dyslipoproteinemia); Known hereditary or acquired predisposition for arterial thrombosis, e.g. hyperhomocysteinemia and anti-phospholipid antibodies (anticardiolipin antibodies, Lupus anticoagulants); Cerebrovascular disease (past cerebral infarction or prodromal states such as transitory ischemia attacks); Past migraine with focal neurological symptoms; Liver disease or pancreatitis; Dubin-Johnson syndrome and Rotor syndrome; Known porphyria; Known or suspected sexual hormone sensitive tumors; Unresolved vaginal bleeding
  • a present severe depressive episode (major depression) according to the DSM V
  • past or present alcohol or drug abuse
  • severe psychiatric disorders (axis I) according to the DSM V (such as bipolar affective disorder or schizophrenia) in addition to anorexia nervosa
  • suicidality
  • known diabetes mellitus
  • severe somatic comorbidity or organ dysfunction that is not compatible with intake of the study drug
  • use of hormonal depot compounds (injectable drugs, implants), or hormonal intrauterine pessaries during the last four weeks before the screening visit (V1)
  • pregnancy
  • breastfeeding during the last 6 months before V1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172533


Locations
Germany
Department of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen Recruiting
Erlangen, Bavaria, Germany, 91054
Contact: Georgios Paslakis, MD, PhD    0049-9131-8534898    georgios.paslakis@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03172533     History of Changes
Other Study ID Numbers: UKER-AN-HS-01
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Erlangen-Nürnberg Medical School:
anorexia nervosa
estrogen
psychotherapy
cortisol
appetite regulation
neurocognitive performance
eating disorder
sexual hormone

Additional relevant MeSH terms:
Anorexia Nervosa
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Estradiol
Polyestradiol phosphate
Estrogens
Ethinyl Estradiol
Dienogest
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents