The effects of anabolic steroids and growth hormone on exercise training and performance.

Question 1

Clinical trials (overview)

Answer 1

• In vitro studies - test products and discover lead compound
• Animal testing - efficacy selectivity mechanism
• Clinical testing
• Marketing

Question 2

Clinical testing (phase overview)

Answer 2

Phase 1 - volunteers
Phase 2 - patients
Phase 3 - large scale multicentre
Phase 4 - Post registration monitoring

Question 3

phase 1 - volunteers studies

- What do they involve

Answer 3

• Pharmacologists & employees (15-30 people)
• Ethical approval
• Healthy
• Informed consent
• Full resuscitation & medical backup
• Monitor
• Single and repeat doses
• Increase dose levels

Question 4

Phase 1 - volunteer studies

- objectives

Answer 4

	Metabolic and excretory pathways
	Variability between individuals; effect of route of administration; bioavailability
	Tolerated dose range
	Indication of therapeutic effects
	Indication of side effects

Question 5

Phase 2 - patient studies

- What do they involve

Answer 5

• 150-350 ill people; informed consent’
• Needs license
• Maximum monitoring; full resuscitation
• Often patients where other treatment failed

Question 6

Phase 2 - patient studies

- Objectives

Answer 6

• Indication for use; type of patient; severity of the disease
• Dose range, schedule and increment; pharmacokinetic studies in ill people; nature of side effects and severity
• Effects in special groups

Question 7

Phase 3 - multicentre studies

Answer 7

• 1500-3500 ill patients
• Multicentre
• More certain data for the objectives of phase 2 studies
• Interactions between drugs start to become measurable in the larger population
• Sub-groups start to be established
• Special features and problems show up

Question 8

Anabolic steroids

Answer 8

Increase in muscle and bone

Question 9

Androgenic steroids

Answer 9

Reproductive and sexual characteristics (hair, voice)

Question 10

How do anabolic steroids work

Answer 10

 Like the natural steroids, the synthetic steroids bind to steroid receptors cell
 The steroid and the receptor are carried to the nucleus and instruct to transcribe mRNA
 mRNA increases protein synthesis and causes muscle growth
 In bone cells – it increases bone size

Question 11

Anabolic steriods

- Effectiveness

Answer 11

dosage is an important factor; training volume accompanies use

Question 12

Abuse of anabolic steroids

Answer 12

o Stacking – combining multiple steroid preparations in oral and injectable form
o Pyramiding – progressively increasing the dosage
Drug quantity used sometimes exceeds the medical does by 40 fold

Question 13

Anabolic steroids

- side effects

Answer 13

 Cystic acne ‘roid rage’, increased plasma lipoproteins
 In males: testicular atrophy
 In females: squaring of the jaw, lowering of voice

Question 14

Double blind

Answer 14

people running trial also doesn’t know who is getting the placebo or the drug

Question 15

what is DHEA

Answer 15

A steroid hormone produced by adrenal glands

Question 16

DHEA

- Claims

Answer 16

• Testosterone booster
• Bolsters immune system
• Preserves youth
• Decreases fatigue and joint pain
• Slows aging
• Invigorates sex life

Question 17

DHEA

- Side effects

Answer 17

• Unregulated compound with uncertain safety

- Elevated plasma DHEA might stimulate the growth of otherwise dormant prostate gland tumours

Question 18

Androstenedione

Answer 18

• Stimulates production of endogenous testosterone
• Enables one to train harder
• Increases muscle mass
• Rapidly repairs tissue injury

Question 19

why can steroids be detected in the urine weeks after use has stopped

Answer 19

Lithophilic drugs like to stay (hide) in the fat tissue – meaning it stays in stores for a long time.

Question 20

Tetrahydrogestrinone

Answer 20

	Often referred to as THG
	Referred to as a designer drug
	Very potent activator of androgen receptors
	Often referred to as ‘the clear’
	The drug was undetectable or invisible