NCT00956813 - 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)

Pruthi S, Qin R, Terstreip SA, Liu H, Loprinzi CL, Shah TR, Tucker KF, Dakhil SR, Bury MJ, Carolla RL, Steen PD, Vuky J, Barton DL
A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North Central
Pruthi S, Qin R, Terstriep SA, et al
: The evaluation of flaxseed for hot flashes: results of a randomized, controlled trial, NCCTG study N08C7. [Abstract] J Clin Oncol 29 (Suppl 15): A-CRA9015, 2011.

Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes

Clinical trial NCT00956813 - References