Effects of transdermal estrogen on Bone Mass in adolescent female patients with Anorexia nervosa (AN) – a placebo-controlled, double-blind, randomized, interventional study

Phase 1

• Conditions: Anorexia nervosa; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-004729-34-DE
• Lead Sponsor: Medical Center- Universtíty of Freiburg Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified