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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