DRKS00014360Not yet recruitingPhase 2
Effects of transdermal estrogen on Bone Mass in adolescent female patients with Anorexia nervosa (AN) – a placebo-controlled, double-blind, randomized, interventional study. - NOV FR04
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- niversitätsklinikum Freiburg
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 14 Years to 20 Years (—)
- Sex
- Female
Inclusion Criteria
- •DSM 5 (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%
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
- •-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)
Investigators
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