NCT01512498 - 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)

Corson SL, Sullivan K, Batzer F, August C, Storb R, Thomas ED
Gynecologic manifestations of chronic graft-versus-host disease. Obstet Gynecol. 1982 Oct;60(4):488-92.
Spinelli S, Chiodi S, Costantini S, Van Lint MT, Raiola AM, Ravera GB, Bacigalupo A
Female genital tract graft-versus-host disease following allogeneic bone marrow transplantation. Haematologica. 2003 Oct;88(10):1163-8.
Zantomio D, Grigg AP, MacGregor L, Panek-Hudson Y, Szer J, Ayton R
Female genital tract graft-versus-host disease: incidence, risk factors and recommendations for management. Bone Marrow Transplant. 2006 Oct;38(8):567-72. Epub 2006 Sep 4.

Vulvovaginal Graft Versus Host Disease in Women Who Underwent Transplantation Before and After Menarche

Clinical trial NCT01512498 - References