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NCT03172533: HOSAN
Estrogen Replacement in Anorexia Nervosa
Phase 2 trial testing ethinyl estradiol 0.03mg and dienogest 2 mg (combination) in Anorexia Nervosa in 11 participants. Terminated before completion.
15 January 2019
Quick facts
| Lead sponsor | University of Erlangen-Nürnberg Medical School |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 15 March 2016 |
| Primary completion | 15 January 2019 |
| Estimated completion | 15 January 2019 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- ethinyl estradiol 0.03mg and dienogest 2 mg (combination) — full drug profile →
- Placebo oral capsule
Conditions studied
- Anorexia Nervosa — all drugs for Anorexia Nervosa →
Sponsor
University of Erlangen-Nürnberg Medical School
Who can join
Adults 18 to 45, female only, with Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Paslakis G, Maas S, Gebhardt B, Mayr A, et al · · 2018 · cited 5× · PMID 29631553 · DOI 10.1186/s12888-018-1683-1
Verify or expand the search:
- PubMed search for NCT03172533
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03172533 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Erlangen-Nürnberg Medical School
- Last refreshed: 30 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03172533.
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