NCT00001412 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Handa RJ, Burgess LH, Kerr JE, O'Keefe JA
Gonadal steroid hormone receptors and sex differences in the hypothalamo-pituitary-adrenal axis. Horm Behav. 1994 Dec;28(4):464-76. Review.
Rubinow DR, Schmidt PJ
Androgens, brain, and behavior. Am J Psychiatry. 1996 Aug;153(8):974-84. Review.
Su TP, Pagliaro M, Schmidt PJ, Pickar D, Wolkowitz O, Rubinow DR
Neuropsychiatric effects of anabolic steroids in male normal volunteers. JAMA. 1993 Jun 2;269(21):2760-4.

The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement

Clinical trial NCT00001412 - References