Estrogen Replacement in Anorexia Nervosa

NCT03172533 | Terminated Phase 2

• 1 other identifier: UKER-AN-HS-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; estrogen; psychotherapy; cortisol; appetite regulation; neurocognitive performance; eating disorder; sexual hormone

Outcome Measures

Primary Outcomes (1)

• Changes in neurocognitive performance

  Performance based on a neurocognitive test battery

  10 weeks of hormonal substitution with an estrogen-progestin-combination

Secondary Outcomes (12)

• Incidence of treatment-emergent adverse Events (AE) (safety/tolerability)

  10 weeks of hormonal substitution with an estrogen-progestin-combination

• Changes in psychopathology (EDE-Q)

  10 weeks of hormonal substitution with an estrogen-progestin-combination

• Changes in psychopathology (EDI-2)

  10 weeks of hormonal substitution with an estrogen-progestin-combination

• Changes in psychopathology (STAI)

  10 weeks of hormonal substitution with an estrogen-progestin-combination

• Changes in psychopathology (Patient Health Questionnaire-9, PHQ-9)

  10 weeks of hormonal substitution with an estrogen-progestin-combination

Study Arms (2)

verum group

ACTIVE COMPARATOR

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)

placebo group

PLACEBO COMPARATOR

placebo

Drug: Placebo oral capsule

Interventions

ethinyl estradiol 0.03mg and dienogest 2 mg (combination) DRUG

approved oral contraceptive (Germany): Maxim

verum group

Placebo oral capsule DRUG

placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (1)

• Paslakis G, Maas S, Gebhardt B, Mayr A, Rauh M, Erim Y. 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. BMC Psychiatry. 2018 Apr 10;18(1):93. doi: 10.1186/s12888-018-1683-1.

  PMID: 29631553 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Ethinyl Estradiol; dienogest

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo-controlled Phase IIa clinical trial in patients with anorexia nervosa

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: June 1, 2017
• Study Start: March 15, 2016
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

DE (1)