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Table 1 A synopsis of study procedures from visit 1 (V1) to visit 7 (V7)

From: 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

  V1 V2 V3 V4 V5 V6 V7
  Screening Baseline Treatment start Week 2 Week 6 Week 10 (EOT) End visit (EOS) week 16
  month − 2 ± 2 day − 3 (±2) day 1 day 15 (±3) day 43 (±3) day 73 (±3) day 113 (±7)
Randomization    X      
Intake of study drug    X------> ----------- ------------ --------X   
Information about study objectives and informed written consent X        
Inclusion and exclusion criteria X X       
Medical history   X       
Sociodemographic data   X       
Anthropometric data (height, weight, waist Circumference, hip circumference, BMI)   X      X  
Weight (BMI)   X X X X   X X
12-channel ECG   X      X  
Urine pregnancy test   X      X  
Vital parameters (HR, RR)   X X X X   X  
Physical examination   X   X    X  
Gynecological examination   X       
Inclusion criteria and contraindications before first intake (gynecological findings, liver parameters, RR etc.)    X      
EDE-Q    X     X X
EDI-2    X     X X
STAI    X     X X
PHQ-9    X     X X
EDQOL    X     X X
Neuropsychological test battery: verbal intelligence test, TMT A and B, Go/NoGo-test with food stimuli, WCST    X     X  
Dexamethasone-suppression test/plasma cortisol concentration (5)    X    X   
Plasma sex hormones (4)   X   X X X   
OGTT for the assessment of plasma ghrelin, leptin, glucose and insulin (6)   X     X   
Routine laboratory tests (1)(2)(3) and urine dipstick   X   X   X   
Assessment of concurrent medication   X X X X X X X
Assessment of adverse events    X X X X X X
  1. 1 hematology: hemoglobin (Hb), hematocrit, red blood cells, white blood cells, platelets, differential blood count, coagulation parameters (Quick/ PTT)
  2. 2 clinical chemistry: sodium, potassium, urea, chloride, creatinine, bilirubin, GOT, GPT, gamma-GT, alcaline phosphatase, lipase, LDH, CRP
  3. 3 fasting lipids
  4. 4 sex hormones: LH, FSH, estradiol, testosterone
  5. 5 dexamethasone-suppression test: 1 mg dexamethasone per os at 11.00 PM followed by fasting blood collection at 08.00 AM for plasma cortisol
  6. 6 OGTT (oral glucose tolerance test): blood draw before intake of glucose suspension (0 min) as well as 30, 60, 90 und 120 min after ingestion
  7. TMT A and B Trail Making Test A and B, WCST Wisconsin Card Sorting Test