Dienogest 2 mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis – VISanne study to assess safety in ADOlescents (VISADO Study) Accepted Manuscript Dienogest 2 mg Daily in[.]
Accepted Manuscript Dienogest mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis – VISanne study to assess safety in ADOlescents (VISADO Study) Andreas D Ebert, MD, PhD, Liying Dong, MD, MSc, Martin Merz, MD, PhD, Bodo Kirsch, MSc, Maja Francuski, MD, Bettina Böttcher, MD, MA, Horace Roman, MD, PhD, Pia Suvitie, MD, Olga Hlavackova, MD, Kerstin Gude, MD, PhD, Christian Seitz, MD, MSc PII: S1083-3188(17)30036-0 DOI: 10.1016/j.jpag.2017.01.014 Reference: PEDADO 2096 To appear in: Journal of Pediatric and Adolescent Gynecology Received Date: 10 August 2016 Revised Date: 10 January 2017 Accepted Date: 20 January 2017 Please cite this article as: Ebert AD, Dong L, Merz M, Kirsch B, Francuski M, Böttcher B, Roman H, Suvitie P, Hlavackova O, Gude K, Seitz C, Dienogest mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis – VISanne study to assess safety in ADOlescents (VISADO Study), Journal of Pediatric and Adolescent Gynecology (2017), doi: 10.1016/j.jpag.2017.01.014 This is a PDF file of an unedited manuscript that has been accepted for publication As a service to our customers we are providing this early version of the manuscript The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain ACCEPTED MANUSCRIPT Dienogest mg Daily in the Treatment of Adolescents with Clinically Suspected Endometriosis – VISanne study to assess safety in ADOlescents (VISADO Study) Andreas D Ebert MD, PhD1, Liying Dong MD, MSc2, Martin Merz MD, PhD2, Bodo Kirsch RI PT MSc2, Maja Francuski MD2, Bettina Böttcher MD, MA3, Horace Roman MD, PhD4,5, Pia Suvitie, MD6, Olga Hlavackova, MD7, Kerstin Gude, MD, PhD2, Christian Seitz MD, MSc2 Praxis for Women’s Health, Gynecology & Obstetrics, Berlin, Germany Bayer AG, Berlin, Germany Department of Gynecologic Endocrinology and Reproductive Medicine, Medical University M AN U Innsbruck, Innsbruck, Austria SC Department of Gynecology and Obstetrics, Rouen University Hospital, Rouen, France, Research Group 4308 ‘Spermatogenesis and Gamete Quality,’ IHU Rouen Normandy, IFRMP23, Reproductive Biology Laboratory, Rouen University Hospital, Rouen, France, Department of Obstetrics and Gynecology, University of Turku and Turku University Hospital, Turku, Finland TE D Gynaecological Rehabilitation Center, Zeyerova 2442, Budějovické předměstí, Písek, EP Czech Republic AC C Financial support: The study was funded by Bayer AG ACCEPTED MANUSCRIPT Disclaimers: Andreas D Ebert has received consulting fees and reimbursement from Bayer Germany, Jenapharm Germany, Takeda Germany, and Gedeon Richter Liying Dong, Martin Merz, Bodo Kirsch, Maja Francuski, and Christian Seitz are full-time employees of RI PT Bayer AG Bettina Böttcher has nothing to disclose Horace Roman has received consulting fees from Nordic Pharma, Bayer, Covidien, Ipsen, and Plasma Surgical Ltd Pia Suvitie has received consulting fees and reimbursements from Gedeon Richter Nordics, MSD, Covidien, AC C EP TE D M AN U SC and Olympus Olga Hlavackova has nothing to disclose ACCEPTED MANUSCRIPT Correspondence: Professor Andreas D Ebert, Praxis for Women’s Health, Gynecology & Obstetrics, Nürnberger Stre 67, 10787 Berlin-Schưneberg, Germany T: +49 (030) 2000 78030, F: +49 (030) 2000 78079 AC C EP TE D M AN U SC RI PT Email: info@prof-ebert.de ACCEPTED MANUSCRIPT Abstract Study objective: To study the safety and efficacy of dienogest mg in adolescents with suspected endometriosis Design: 52-week, open-label, single-arm study RI PT Setting: 21 study centers, six European countries Participants: Adolescents aged 12 to