Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-01-07 @ 7:59 AM
Study NCT ID:
NCT03172533
Status:
TERMINATED
Last Update Posted:
2019-01-30
First Post:
2017-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estrogen Replacement in Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C023635', 'term': 'dienogest'}], 'ancestors': [{'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double-blinded study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, placebo-controlled Phase IIa clinical trial in patients with anorexia nervosa'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Difficulties in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in neurocognitive performance', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Performance based on a neurocognitive test battery'}], 'secondaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse Events (AE) (safety/tolerability)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Number of adverse events (including AE, AR, severe AE, SAR and SUSAR)'}, {'measure': 'Changes in psychopathology (EDE-Q)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in sum scores in the EDE-Q'}, {'measure': 'Changes in psychopathology (EDI-2)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in sum scores in the EDI-2'}, {'measure': 'Changes in psychopathology (STAI)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in sum scores in the STAI'}, {'measure': 'Changes in psychopathology (Patient Health Questionnaire-9, PHQ-9)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in sum scores in the PHQ-9'}, {'measure': 'Changes in psychopathology (Eating Disorder Quality of Life, EDQoL)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in sum scores in the EDQoL'}, {'measure': 'Neuroendocrinological changes (cortisol)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in plasma cortisol levels during a dexamethasone suppression test'}, {'measure': 'Neuroendocrinological changes (glucose)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in plasma concentrations of glucose'}, {'measure': 'Neuroendocrinological changes (insulin)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in plasma concentrations of insulin'}, {'measure': 'Neuroendocrinological changes (ghrelin)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in plasma concentrations of the appetite-regulating peptide ghrelin'}, {'measure': 'Neuroendocrinological changes (leptin)', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in plasma concentrations of the appetite-regulating peptide leptin'}, {'measure': 'Changes in antidepressant medication', 'timeFrame': '10 weeks of hormonal substitution with an estrogen-progestin-combination', 'description': 'Changes in antidepressants´ use'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anorexia nervosa', 'estrogen', 'psychotherapy', 'cortisol', 'appetite regulation', 'neurocognitive performance', 'eating disorder', 'sexual hormone'], 'conditions': ['Anorexia Nervosa']}, 'referencesModule': {'references': [{'pmid': '29631553', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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).', 'detailedDescription': '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.\n\nPrimary 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.\n\nSecondary targets:\n\n* Examination of safety and tolerability of sexual hormone replacement using an estrogen-progestin-combination in patients with anorexia nervosa.\n* 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).\n* Assessment of the impact of substitution upon anxiety (STAI)\n* Assessment of the impact on cortisol levels\n* Assessment of the impact on appetite-regulating plasma peptides\n* Assessment of the impact on the prescription of antidepressants'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* BMI ≥ 13 kg/m2 and ≤ 18.5 kg/m2\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* a known hypersensitivity to the active compound or to other components of the study drug\n* 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\n* a present severe depressive episode (major depression) according to the DSM V\n* past or present alcohol or drug abuse\n* severe psychiatric disorders (axis I) according to the DSM V (such as bipolar affective disorder or schizophrenia) in addition to anorexia nervosa\n* suicidality\n* known diabetes mellitus\n* severe somatic comorbidity or organ dysfunction that is not compatible with intake of the study drug\n* use of hormonal depot compounds (injectable drugs, implants), or hormonal intrauterine pessaries during the last four weeks before the screening visit (V1)\n* pregnancy\n* breastfeeding during the last 6 months before V1'}, 'identificationModule': {'nctId': 'NCT03172533', 'acronym': 'HOSAN', 'briefTitle': 'Estrogen Replacement in Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UKER-AN-HS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'verum group', 'description': 'approved oral contraceptive: ethinyl estradiol 0.03mg and dienogest 2mg (combination drug) daily intake over 10 weeks', 'interventionNames': ['Drug: ethinyl estradiol 0.03mg and dienogest 2 mg (combination)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'placebo', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'ethinyl estradiol 0.03mg and dienogest 2 mg (combination)', 'type': 'DRUG', 'description': 'approved oral contraceptive (Germany): Maxim', 'armGroupLabels': ['verum group']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}