NCT01953796 - 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)

Bates GW, Shomento S, McKnight K, McLean HM
Novel clomiphene protocol in polycystic ovarian syndrome: Hurst et al. Am J Obstet Gynecol. 2009 May;200(5):586-7. doi: 10.1016/j.ajog.2009.02.019.
Hurst BS, Hickman JM, Matthews ML, Usadi RS, Marshburn PB
Novel clomiphene "stair-step" protocol reduces time to ovulation in women with polycystic ovarian syndrome. Am J Obstet Gynecol. 2009 May;200(5):510.e1-4. doi: 10.1016/j.ajog.2008.10.031. Epub 200

Study of Stair-step Clomiphene Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome (PCOS) Compared to Traditional Protocol.

Clinical trial NCT01953796 - References