Comparison of treatment with sexual hormones and psychotherapy over 10 weeks vs. psychotherapy only in adult females with anorexia nervosa

Prospective, randomised, double-blind, placebo-controlled, single centre phase IIa clinical trial to investigate the safety and tolerability as well as the impact of a substitution of sexual hormones with an estrogen-progestin combination over 10 weeks in addition to in-house psychotherapy on neuro-endocrinological parameters, psychopathology and neuro-psychological performance compared to in-house psychotherapy alone in adult females with anorexia nervosa - HOSAN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004184-36-DE

Enrollment

Registered

2015-12-09

Start date

2016-01-05

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substitution of sexual hormones in adult females with anorexia nervosa MedDRA version: 18.1 Level: LLT Classification code 10063915 Term: Substitution therapy System Organ Class: 100000004865

Interventions

Trade Name: Maxim Pharmaceutical Form: Capsule INN or Proposed INN: ETHINYLESTRADIOL CAS Number: 59-05-2 Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female subject 18 to 45 years of age Anorexia nervosa Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known hypersentivity to active substances and other ingredients of the IMP Known contra-indication to hormonal contraception Acute major depression Known acute alcohol or drug abuse Severe psychological/psychiatric disorder in addition to anorexia nervosa Acute suicidality Known diabetes mellitus Known severe concomitant disease Use of hormonal depot preparation Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Quantification of the impact of the substitution of sexual hormones with an estrogen-progestin combination in addition to in-house psychotherapy on the neuro-psychological performance of female subjects with anorexia nervosa, measured by WST, TMT A and B, Go/NoGo test and WCST ; Secondary Objective: Quantification of the impact of the substitution of sexual hormones on the psychopathology , measured by the EDE-Q. Quantification of the impact of the substitution of sexual hormones on the psychopathology, measured by the EDI-2. Quantification of the impact of the substitution of sexual hormones on anxiousness. Quantification of the impact of the substitution of sexual hormones on cortisal plasma levels. Quantification of the impact of the substitution of sexual hormones on sexual hormone plasma levels. Quantification of the impact of the substitution of sexual hormones on plasma levels of appetite-regulating peptids. Quantification of the impact of the substitution of sexual hormones on the use of antidepressants. Assessment of safety and tolerability of the IMP. ;Primary end point(s): Change of the neuropsychological performance measured by WST, TMT A and B, Go/NoGo test and WCST after 10 weeks of psychotherapy and sexual hormone substitution compared to baseline in the intervention group vs the group with psychotherapy alone.;Timepoint(s) of evaluation of this end point: 10 weeks after intervention start	—

Measure

Time frame

Main Objective: Quantification of the impact of the substitution of sexual hormones with an estrogen-progestin combination in addition to in-house psychotherapy on the neuro-psychological performance of female subjects with anorexia nervosa, measured by WST, TMT A and B, Go/NoGo test and WCST ; Secondary Objective: Quantification of the impact of the substitution of sexual hormones on the psychopathology , measured by the EDE-Q. Quantification of the impact of the substitution of sexual hormones on the psychopathology, measured by the EDI-2. Quantification of the impact of the substitution of sexual hormones on anxiousness. Quantification of the impact of the substitution of sexual hormones on cortisal plasma levels. Quantification of the impact of the substitution of sexual hormones on sexual hormone plasma levels. Quantification of the impact of the substitution of sexual hormones on plasma levels of appetite-regulating peptids. Quantification of the impact of the substitution of sexual hormones on the use of antidepressants. Assessment of safety and tolerability of the IMP. ;Primary end point(s): Change of the neuropsychological performance measured by WST, TMT A and B, Go/NoGo test and WCST after 10 weeks of psychotherapy and sexual hormone substitution compared to baseline in the intervention group vs the group with psychotherapy alone.;Timepoint(s) of evaluation of this end point: 10 weeks after intervention start

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Secondary

Measure	Time frame
Secondary end point(s): Change in scores of subscales "eating concern", "weight concern" and "shape concern" measured by the EDE-Q Change in psychopathology measured by EDI-2 Change in anxiousness scores Change in depressive co-morbidity Change in quality of life associated with eating disorders Change of plasma cortisol levels during a dexamethason suppression test Change of sexual hormone plasma levels Change of plasma levels of appetite-regulating peptids Change in use of antidepressants Number of AE, AR, SAE, SAR and SUSAR ;Timepoint(s) of evaluation of this end point: 10 weeks after start of intervention	—

Measure

Time frame

Secondary end point(s): Change in scores of subscales "eating concern", "weight concern" and "shape concern" measured by the EDE-Q Change in psychopathology measured by EDI-2 Change in anxiousness scores Change in depressive co-morbidity Change in quality of life associated with eating disorders Change of plasma cortisol levels during a dexamethason suppression test Change of sexual hormone plasma levels Change of plasma levels of appetite-regulating peptids Change in use of antidepressants Number of AE, AR, SAE, SAR and SUSAR ;Timepoint(s) of evaluation of this end point: 10 weeks after start of intervention

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Countries

Germany

Contacts

Public ContactPsychosomatische Abteilung

Universitätsklinikum Erlangen

georgios.paslakis@uk-erlangen.de0049 91318534898

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026