TerminatedNCT03172533HOSANUpdated Jan 30, 2019

Estrogen Replacement in Anorexia Nervosa

A Phase 2 interventional study of ethinyl estradiol 0.03mg and dienogest 2 mg (combination) and Placebo oral capsule in Anorexia Nervosa, sponsored by University of Erlangen-Nürnberg Medical School. Terminated at 1 site in Germany. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-01-30.

Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2, Interventional, and Treatment

Why this study was terminated

Difficulties in recruitment

From the registry’s dates

Registered 1 year 2 months after the study started (first participant enrolled Mar 2016, registered May 2017).

Phase: Phase 2
Study type: Interventional
Enrollment: 11
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: Female

Study 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).

Read the 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

Conditions studied

Anorexia Nervosa

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Keywords

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

In context

Anorexia Nervosa

462 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's enrollment of 11 is below the median of 43 across 311 interventional studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.

Browse University of Erlangen-Nürnberg Medical School studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 11 participants (actual)

Study arms

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)
Placebo comparator
placebo group
placebo
Drug: Placebo oral capsule

Interventions

Drugethinyl estradiol 0.03mg and dienogest 2 mg (combination)
Drug page: Ethinyl Estradiol
approved oral contraceptive (Germany): Maxim
DrugPlacebo oral capsule
placebo

What researchers measure

Primary outcomes

Changes in neurocognitive performance
Performance based on a neurocognitive test battery
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination

Secondary outcomes

Incidence of treatment-emergent adverse Events (AE) (safety/tolerability)
Number of adverse events (including AE, AR, severe AE, SAR and SUSAR)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDE-Q)
Changes in sum scores in the EDE-Q
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDI-2)
Changes in sum scores in the EDI-2
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (STAI)
Changes in sum scores in the STAI
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (Patient Health Questionnaire-9, PHQ-9)
Changes in sum scores in the PHQ-9
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (Eating Disorder Quality of Life, EDQoL)
Changes in sum scores in the EDQoL
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (cortisol)
Changes in plasma cortisol levels during a dexamethasone suppression test
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (glucose)
Changes in plasma concentrations of glucose
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (insulin)
Changes in plasma concentrations of insulin
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (ghrelin)
Changes in plasma concentrations of the appetite-regulating peptide ghrelin
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (leptin)
Changes in plasma concentrations of the appetite-regulating peptide leptin
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in antidepressant medication
Changes in antidepressants´ use
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination

Study locations

1 site

Department of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen
Erlangen, Bavaria 91054, Germany

References and documents

Publications

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. PubMed 29631553 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in Jan 2019, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered: May 22, 2017
First posted: Jun 1, 2017
StartActual: Mar 15, 2016
Primary completionActual: Jan 15, 2019
CompletionActual: Jan 15, 2019
Last update: Jan 30, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03172533
Lead sponsor: University of Erlangen-Nürnberg Medical School
Responsible party: Sponsor
First posted: Jun 1, 2017
Start date: Mar 15, 2016
Primary completion: Jan 15, 2019
Completion: Jan 15, 2019
Last update: Jan 30, 2019

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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