Anorexia NervosaPhase 2HOSANNCT03172533
Estrogen Replacement in Anorexia Nervosa
A Phase 2 study testing ethinyl estradiol 0.03mg and dienogest 2 mg (combination) in people with Anorexia Nervosa, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- ethinyl estradiol 0.03mg and dienogest 2 mg (combination)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2016to 15 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychosomatic Medicine and Psychotherapy, University Hospital Erlangen
Erlangen, Bavaria, 91054
About this study
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
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
- Anorexia Nervosa
- Being tested
- ethinyl estradiol 0.03mg and dienogest 2 mg (combination), Placebo oral capsule
- Keywords
- anorexia nervosa, estrogen, psychotherapy, cortisol, appetite regulation, neurocognitive performance, eating disorder, sexual hormone
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethinyl estradiol 0.03mg and dienogest 2 mg (combination)Drug
approved oral contraceptive (Germany): Maxim
Placebo oral capsuleDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| verum group | Active comparator | approved oral contraceptive: ethinyl estradiol 0.03mg and dienogest 2mg (combination drug) daily intake over 10 weeks Receives: Drug: ethinyl estradiol 0.03mg and dienogest 2 mg (combination) |
| placebo group | Placebo comparator | placebo Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neurocognitive performance
Performance based on a neurocognitive test battery
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Secondary outcomes (12)
Incidence of treatment-emergent adverse Events (AE) (safety/tolerability)
Number of adverse events (including AE, AR, severe AE, SAR and SUSAR)
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDE-Q)
Changes in sum scores in the EDE-Q
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDI-2)
Changes in sum scores in the EDI-2
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (STAI)
Changes in sum scores in the STAI
Measured: 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
Measured: 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
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (cortisol)
Changes in plasma cortisol levels during a dexamethasone suppression test
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (glucose)
Changes in plasma concentrations of glucose
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (insulin)
Changes in plasma concentrations of insulin
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (ghrelin)
Changes in plasma concentrations of the appetite-regulating peptide ghrelin
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (leptin)
Changes in plasma concentrations of the appetite-regulating peptide leptin
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in antidepressant medication
Changes in antidepressants´ use
Measured: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 Mar 2016
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Why it stopped: Difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo-controlled Phase IIa clinical trial in patients with anorexia nervosa
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172533
- Sponsor's protocol ID
- UKER-AN-HS-01
- Acronym
- HOSAN
- Status last verified
- Jan 2019
- First submitted
- 22 May 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03172533
- Acronym / sponsor ID
- HOSAN / UKER-AN-HS-01
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, estrogen, psychotherapy, cortisol, appetite regulation, neurocognitive performance, eating disorder, sexual hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled Phase IIa clinical trial in patients with anorexia nervosa
| Arm | Type | Receives |
|---|---|---|
| verum group | Active comparator | Drug: ethinyl estradiol 0.03mg and dienogest 2 mg (combination)approved oral contraceptive: ethinyl estradiol 0.03mg and dienogest 2mg (combination drug) daily intake over 10 weeks |
| placebo group | Placebo comparator | Drug: Placebo oral capsuleplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethinyl estradiol 0.03mg and dienogest 2 mg (combination)approved oral contraceptive (Germany): Maxim | Drug | verum group |
| Placebo oral capsuleplacebo | Drug | placebo group |
Primary outcome
Changes in neurocognitive performance
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Performance based on a neurocognitive test battery
12 secondary outcomes
Incidence of treatment-emergent adverse Events (AE) (safety/tolerability)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDE-Q)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (EDI-2)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (STAI)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (Patient Health Questionnaire-9, PHQ-9)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in psychopathology (Eating Disorder Quality of Life, EDQoL)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (cortisol)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (glucose)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (insulin)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (ghrelin)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Neuroendocrinological changes (leptin)
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Changes in antidepressant medication
Time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination
Results and safety
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 29631553Paslakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ethinyl estradiol 0.03mg and dienogest 2 mg (combination) in people with Anorexia Nervosa, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neurocognitive performance (time frame: 10 weeks of hormonal substitution with an estrogen-progestin-combination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.