Jacques Donnez, M. D. , Olivier Donnez, M. D. , Dace Matule, M. D

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Presentation transcript:

Long-term medical management of uterine fibroids with ulipristal acetate Jacques Donnez, M.D., Olivier Donnez, M.D., Dace Matule, M.D., Hans-Joachim Ahrendt, M.D., Robert Hudecek, M.D., Janos Zatik, M.D., Zaneta Kasilovskiene, M.D., Mihai Cristian Dumitrascu, M.D., Hervé Fernandez, M.D., David H. Barlow, F.R.C.O.G., Philippe Bouchard, M.D., Bart C.J.M. Fauser, M.D., Elke Bestel, M.D., Ernest Loumaye, M.D. Fertility and Sterility Volume 105, Issue 1, Pages 165-173.e4 (January 2016) DOI: 10.1016/j.fertnstert.2015.09.032 Copyright © 2016 The Authors Terms and Conditions

Figure 1 Percentage of patients with endometrial thickness >16 mm (safety population). ∗After treatment course + 1 bleed. N = number of patients in whom endometrial thickness was measured; UPA = ulipristal acetate. Fertility and Sterility 2016 105, 165-173.e4DOI: (10.1016/j.fertnstert.2015.09.032) Copyright © 2016 The Authors Terms and Conditions

Supplemental Figure 1 Schedule of treatments and visits. Fertility and Sterility 2016 105, 165-173.e4DOI: (10.1016/j.fertnstert.2015.09.032) Copyright © 2016 The Authors Terms and Conditions

Supplemental Figure 2 PBAC, one of the current standard methods used to objectively estimate menstrual blood loss and diagnose menorrhagia. The method that was developed and validated by Higham and Janssen defines excessive bleeding as a PBAC score >100. Fertility and Sterility 2016 105, 165-173.e4DOI: (10.1016/j.fertnstert.2015.09.032) Copyright © 2016 The Authors Terms and Conditions

Supplemental Figure 3 Patient disposition. Withdrawals are presented according to the timeframes in which they occurred, either during treatment or after treatment completion for each course. Two subjects randomized to the UPA 10 mg group received UPA 5 mg treatment in error; these subjects are included in the FAS sets according to randomization and in the safety set according to treatment received. Fertility and Sterility 2016 105, 165-173.e4DOI: (10.1016/j.fertnstert.2015.09.032) Copyright © 2016 The Authors Terms and Conditions

Supplemental Figure 4 Amenorrhea and/or fibroid volume reduction. Percentage of subjects with amenorrhea and/or a clinically significant reduction in fibroid volume (>25%). Fertility and Sterility 2016 105, 165-173.e4DOI: (10.1016/j.fertnstert.2015.09.032) Copyright © 2016 The Authors Terms and Conditions