Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study Lynnette.

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Presentation transcript:

Efficacy and tolerability of CDB-2914 treatment for symptomatic uterine fibroids: a randomized, double-blind, placebo-controlled, phase IIb study Lynnette K. Nieman, M.D., Wendy Blocker, R.N., Tonja Nansel, Ph.D., Sheila Mahoney, M.S., C.N.M., M.P.H., James Reynolds, M.D., Diana Blithe, Ph.D., Robert Wesley, Ph.D., Alicia Armstrong, M.D. Fertility and Sterility Volume 95, Issue 2, Pages 767-772.e2 (February 2011) DOI: 10.1016/j.fertnstert.2010.09.059 Copyright © 2011 Terms and Conditions

Figure 1 Patient flow through the protocol. Women were enrolled beginning on 3/16/2006. The final magnetic resonance imaging (MRI) of the extension study was obtained on 6/8/09. Ph 2 = treatment 2, Surg = surgery, Myo = myomectomy, Hyster = hysterectomy, Ext = extension study. Reasons for dropping out are provided by superscripts: adid not pick up medication; bdid not want to have second MRI; chad severe headache; dhad an out-of-body experience; estudy was inconvenient. Fertility and Sterility 2011 95, 767-772.e2DOI: (10.1016/j.fertnstert.2010.09.059) Copyright © 2011 Terms and Conditions

Figure 2 Vaginal bleeding during treatment 1. PLC = placebo; CDB = P receptor modulator CDB-2914. Fertility and Sterility 2011 95, 767-772.e2DOI: (10.1016/j.fertnstert.2010.09.059) Copyright © 2011 Terms and Conditions

Figure 3 Liver function abnormalities (LFT) in treatments 1 and 2. All abnormal aspartate aminotransferase (AST) (closed squares during treatment; open squares at baseline) and alanine aminotransferase (ALT) (closed circles) results are shown. All women with abnormal values received P receptor modulator CDB-2914. The solid line represents the upper limit of normal for aspartate aminotransferase and the dashed line shows the upper limit of normal for alanine aminotransferase. The number of normal results during the study for each patient is shown at the bottom of the graph. At the end of the study, patient 8 had normal values; patient 9 had values within 3 U/L of the upper limit of normal; all other patients had normal results except for the minor increase in alanine aminotransferase in patients 5 and 7. Fertility and Sterility 2011 95, 767-772.e2DOI: (10.1016/j.fertnstert.2010.09.059) Copyright © 2011 Terms and Conditions