NCT00001221 - 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)

Raiti S, Moore WV, Van Vliet G, Kaplan SL
Growth-stimulating effects of human growth hormone therapy in patients with Turner syndrome. J Pediatr. 1986 Dec;109(6):944-9.
Rosenfeld RG, Hintz RL, Johanson AJ, Brasel JA, Burstein S, Chernausek SD, Clabots T, Frane J, Gotlin RW, Kuntze J, et al
Methionyl human growth hormone and oxandrolone in Turner syndrome: preliminary results of a prospective randomized trial. J Pediatr. 1986 Dec;109(6):936-43.
Urban MD, Lee PA, Dorst JP, Plotnick LP, Migeon CJ
Oxandrolone therapy in patients with Turner syndrome. J Pediatr. 1979 May;94(5):823-7.

A Double-Blind, Randomized, Placebo-Controlled Trial of the Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome

Details for clinical trial NCT00001221

Clinical trial NCT00001221 - References