Anorexia nervosa
Conditions
Interventions
Trade Name: Estramon100µg/24h
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 50-28-2
Conc
Sponsors
Medical Center- Universtíty of Freiburg Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Subjects who meet all of the following inclusion criteria will be eligible for enrollment in the study: • DSM V (307.1) for Anorexia nervosa • Amenorrhea for a minimum of 3 months preceding study participation • Age 14-20 years • Bone age = 14 years • BMI-Percentile = 5% • The patient, if a female of childbearing potential and sexually active, must use a copper IUD (Intra Uterine Device). Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Primary amenorrhea • Premature ovarian failure, as demonstrated by an elevated FSH • Diseases known to affect bone metabolism including: ? untreated thyreoid disease ? cushing syndrome ? diabetes ? pituitary disease ? renal failure ? prior bone fracture within 6 months of the study • Medication known to affect bone metabolism (including gonadal steroids within the last 3 months) • Evidence of: ? Suicidality ? Psychosis ? Substance abuse • Abnormal TSH • Hematocrit < 30% Potassium < 3,0 mmol/l Glucose < 50 mg/dl • Pregnancy/lactation • History of malignancy • Contraindications to estrogen therapy (for girls with AN) Smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to determine the effect of continuously transdermal applicated 100 µg 17-ß-estradiol with cyclic 10 mg dydrogesterone orally given on Bone Mineral Density (BMD) veryfied by dual energy x-ray absorptiometry (DXA) in L1-L4.;Secondary Objective: The secondary objective of the study is to determine the effect of continuously transdermal applicated 100 µg 17-ß-estradiol with cyclic 10 mg dydrogesterone orally given on Bone Mineral Density (BMD) veryfied by dual energy x-ray absorptiometry (DXA) in the hip.; Timepoint(s) of evaluation of this end point: DXA: Baseline 12 months Duration of treatment per patient: one year (13 months/28 days) ; Primary end point(s): Primary efficacy endpoint: The primary endpoint of the study is to determine the effect of continuously transdermal applicated 100µg 17-ß-estradiol with cyclic 10mg dydrogesterone orally given on Bone Mineral Density (BMD) veryfied by dual energy x-ray absorptiometry (DXA). A significant change in BMD z-scores in spine L1-L4 is expected in the experimental group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: DXA: Baseline 12 months Duration of treatment per patient: one year (13 months/28 days) ; Secondary end point(s): Secondary efficacy endpoint: Significant change in BMD z-score in hip in experimental group Assessment of safety: regular assessment of(serious) adverse Events((S)AE) and laboratory controls during active treatment. | — |
Countries
Germany
Contacts
Public Contactstudy coordinator
Medical Center- Universtíty of Freiburg Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics
Outcome results
None listed