Fibroids Uterine

Total Page:16

File Type:pdf, Size:1020Kb

Fibroids Uterine 3RD CONGRESS OF THE SOCIETY SEUD OF ENDOMETRIOSIS AND UTERINE DISORDERS Congress 201 7 & UTERINE FIBROIDS BLEEDING: UNLOCKING2017 THE ISSUES APRIL 6, 7, 8 SINGAPORE Location Congress President SEUD President SUNTEC Convention Pr Yoke Fai Fong, Singapore Pr Charles Chapron, France & Exhibition Centre, Singapore WWW.SEUD.ORG TABLE OF CONTENTS 02 WELCOME LETTER 03 FACULTY & INTERNATIONAL COMMITTEE 04 PROGRAM AT A GLANCE SCIENTIFIC PROGRAM 06 WEDNESDAY, APRIL 5TH 07 THURSDAY, APRIL 6TH 08 FRIDAY, APRIL 7TH 12 SATURDAY, APRIL 8TH 14 PARTNERS 16 EXHIBITION MAP WELCOME TO SINGAPORE Dear friends and colleagues, It is with great pleasure that I welcome you to join us in Singapore in 2017 for the SEUD Congress. This is the third meeting for this exciting Congress and the first time it will be held in Asia, from April 6th - 8th 2017. Singapore is in the heart of Asia, with Changi Airport having more than 100 airlines flying to some 330 cities in about 80 countries and territories worldwide. Singapore is distinctive in combining the best of East meets West, with a modern and efficient infrastructure, yet very much retaining the uniqueness and charm of Asian culture. The theme for the 2017 Congress is “Fibroids and uterine bleeding: unlocking the issues”. Up to a third of women have fibroids and many more have some form of abnormal uterine Boards bleeding during their lifetime. It is an appropriate opportunity for us to unlock the issues and controversies and we have the privilege to host internationally renowned speakers known for Congress their expertise at this meeting. President Yoke Fai Fong Not forgetting the ideals of our first two Congresses, we will still continue to feature both Co-chairs Endometriosis and Adenomyosis in the scientific program. The width, breadth and depth of the Sun Wei Guo topics to be discussed, with live surgeries, key note lectures, plenaries, debates, workshops, Jim Tsaltas National sessions etc, will certainly make this a very exciting Congress for its high level Local organizing scientific content. committee Anupriya Agarwal Singapore is the springboard to the regional countries and itself is a unique and exciting Nainda Calustre tourist destination. The Congress venue itself is in the heart of the city, with the famous Karen Lim Marina Bay as the backdrop, and the Gala Dinner itself will be held at the Gardens by the Bay, Harvard Lin an attraction that has won multiple awards such as the THEA award, World Building of the Year Li Ma award, TripAdvisor Travellers’ choice awards and many more. Kai Lyn Ng Ying Woo Ng We look forward to seeing you here in 2017. Judith Ong Bharti Parikh Shakina Rauff Pr Yoke Fai Fong Meilan Xie President of the 3rd SEUD Congress 2 SEUD Congress RD WELCOME TO SINGAPORE 3 CONGRESS OF THE SOCIETY OF ENDOMETRIOSIS AND UTERINE DISORDERS 201 7 Faculty & international committee Mauricio Abrao, Brazil Ian Fraser, Australia Alex Ooi, Singapore Anupriya Agarwal, Singapore Caroline Gargett, Australia Yutaka Osuga, Japan Angela Aguilar, Philippines Sun-Wei Guo, China Yoshiaki Ota, Japan Saeed Alborzi, Iran Wachyu Hadisaputra, Indonesia Resad Pasic, USA Masaaki Andou, Japan Tasuku Harada, Japan Felice Petraglia, Italy Suan Tiong Beh, Singapore Andon Hestiantoro, Indonesia Paola Piomboni, Italy Arijit Biswas, Singapore Sarah Holdsworth-Carson, Australia Alexander Popov, Russia Giuliano Borrelli, Brazil Tew Hong Ho, Singapore Jaron Rabinovici, Israel Serdar Bulun, USA Kathy Huang, USA Yunyun Ren, China German Tan Cardoso, Philippines Khaleque Khan, Japan Peter Rogers, Australia Francisco Carmona, Spain Rosanne M. Kho, USA Juan L. Salgado, Puerto Rico Amphan Chalermchokcharoenkit, Thailand Chit Chong Khong, Singapore Pietro Santulli, France Cathryn Chan, Singapore Su-Yen Khong, Malaysia Kaiyin See Tho, Singapore Jerry Chan, Singapore Chong Kiat Khoo, Singapore Gamal Serour, Egypt Charles Chapron, France Sung Hoon Kim, Korea Sony Singh, Canada Miguel Angel Checa, Spain Chung Fai Koh, Singapore Edgardo Somigliana, Italy Jin-Yun Chen, China Alka Kriplani, India Elizabeth Stewart, USA Yi Jen Chen, Taiwan Philippe Y. Laberge, Canada Ann Tan, Singapore Zi-Jiang Chen, China Keen Whye Lee, Singapore Yew Ghee Tan, Singapore Bernard Chern, Singapore Jin Hua Leng, China Maruyama Tetsuo, Japan Vincent Cheung, Hong Kong Susan Logan, Singapore Jim Tsaltas, Australia Si Hyun Cho, Korea Anne-Elodie Millischer, France Peng-Hui Wang, Taiwan Kah Kiong Chow, Singapore Malcom Munro, USA Lip Kee Yap, Singapore Hilary Critchley, United Kingdom Suresh Nair, Singapore Eu-Leong Yong, Singapore Magrit Dueholm, Denmark Haider Najjar, Australia Scott Young, USA Yoke Fai Fong, Singapore Soon Chye Ng, Singapore Su Ling Yu, Singapore Hervé Fernandez, France Ying Woo Ng, Singapore Xin Mei Zhang, China 3 PROGRAM AT A GLANCE WEDNESDAY, APRIL 5TH THURSDAY, APRIL 6TH 07:30 08:00 WELCOME DESK OPENING 08:30 Welcome coffee S 09:00 A 331 09:30 MYOMECTOMY WORKSHOPS SIMULTANEOUS ALGERIAN Myomectomy morning course LIVE SURGERIES SESSION 10:00 SPONSORED BY FROM NATIONAL UNIVERSITY HOSPITAL 10:30 11:00 Coffee break 328 331 333 A 11:30 JAPANESE CHINESE INDIAN SESSION SESSION SESSION 12:00 MYOMECTOMY WORKSHOPS Myomectomy morning course S BENIGN 12:30 GYNAECOLOGICAL Cocktail lunch CONDITIONS… & exhibition visit 13:00 S Lunch OPENING CEREMONY 13:30 B S KEYNOTE LECTURE STATE OF THE ART Uterine fibroids: impact on women’s health 14:00 ON THE IMAGING A DIAGNOSIS OF ENDOMETRIOSIS S 14:30 AND ADENOMYOSIS SPONSORED BY PATHOGENESIS OF UTERINE FIBROIDS 15:00 15:30 MYOMECTOMY WORKSHOPS Coffee break Myomectomy hands-on session Coffee break & exhibition visit B 16:00 STATE OF THE ART S 16:30 ON THE IMAGING DIAGNOSIS OF ENDOMETRIOSIS AND ADENOMYOSIS 17:00 ADENOMYOSIS: WELCOME FROM DIAGNOSIS TO MODERN MANAGEMENT DESK OPENING 17:30 AT SUNTEC 18:00 18:30 Welcome reception & posters visit 19:00 A Venue: S Advanced Surgery Training Centre (ASTC) National University Hospital SUMMIT 1 (PLENARY ROOM) 327 328 … ROOMS 327, 328… B Venue: Seminar Room T12-03, National University Health System Tower Block Level 12 4 SEUD Congress RD 3 CONGRESS OF THE SOCIETY OF ENDOMETRIOSIS AND UTERINE DISORDERS 201 7 FRIDAY, APRIL 7TH SATURDAY, APRIL 8TH 07:30 S 08:00 328 S UTERINE FIBROIDS: 328 NEW THERAPEUTIC DEVELOPMENT 08:30 SPONSORED BY NEW TOOLS IN ENDOMETRIOSIS FIELDS LATIN RUSSIAN AMERICAN 09:00 SESSION SESSION 09:30 S KEYNOTE LECTURE Endometriosis management: time to reconsider the paradigm S KEYNOTE LECTURE 10:00 HMB, the symptom, the hormonal therapies and integral supplemental medication Coffee break & exhibition visit S 327 328 331 332 10:30 S 327 328 331 332 333 FREE FREE FREE FREE Coffee break CELEBRATING WOMEN, VIDEOS COM. COM. COM. COM. 11:00 TRANSFORMING LIVES SESSION 10 11 12 13 FREE FREE FREE FREE FREE COM. COM. COM. COM. COM. Coffee break & exhibition visit 11:30 S 1 2 3 4 5 NEW MODALITIES S 331 IN HAEMOSTASIS DEBATE 12:00 DEBATE Medical treatment of uterine Infertility and DIE: surgery first or ART? fibroids as first line therapy: yes or no? 12:30 S 331 DEBATE 328 DEBATE The world should just ignore S Fresh the FDA advisory and carry on with 13:00 versus frozen transfer UTERINE FIBROIDS AND INFERTILITY morcellation of fibroids / large uteri APAGE SPONSORED BY SESSION S BREAKING DOWN 13:30 THE PATHWAY TO PAIN MANAGEMENT IN ENDOMETRIOSIS Cocktail lunch & exhibition visit 14:00 SPONSORED BY S AWARDS & CLOSING CEREMONY 14:30 S SEUD ASSEMBLY 15:00 S 327 331 332 333 328 331 332 TRUCLEAR / A MINIMALLY INVASIVE OPTION FREE FREE FREE FREE CANADIAN 15:30 FOR ADDRESSING… COM. COM. COM. COM. SESSION 6 7 8 9 SPONSORED BY PATIENTS SESSION 16:00 Coffee break & exhibition visit 16:30 S 327 17:00 ABNORMAL UTERINE BLEEDING (AUB): MIDDLE EAST HOW “PALM-COEIN” HELPS US MANAGE OUR PATIENTS SESSION 17:30 18:00 SEUD social evening at the Gardens by the Bay (shuttle departure) 18:30 SPONSORED BY 19:00 5 SCIENTIFIC PROGRAM WEDNESDAY, APRIL 5TH PRE-COURSES (compulsory registration) 08:30 Myomectomy workshops SPONSORED BY 13:00 State of the art SPONSORED BY 17:00 Organizer: Yoke Fai Fong (Singapore) 17:30 on the imaging diagnosis Venue: Advanced Surgery Training Centre (ASTC) of endometriosis and adenomyosis National University Hospital Chairs: Mauricio Abrao (Brazil) 08:30 Registration & breakfast & Arijit Biswas (Singapore) 09:00 Myomectomy morning course Venue: National University Health System NUHS Tower Block Welcome address, Yoke Fai Fong (Singapore) 13:00 Registration & lunch - How to reduce bleeding at myomectomy? 13:30 Welcome address, Mauricio Abrao (Brazil) Yoke Fai Fong (Singapore) & Arijit Biswas (Singapore) - Atypical locations: cervical and broad - TVS US versus MRI for the diagnosis ligament fibroids, Alexander Popov (Russia) of endometriosis: which is the best method? - Laparoscopic myomectomy and risk of uterine rupture, Anne-Elodie Millischer (France) Vincent Cheung (Hong Kong) - TVS in diagnosis of DIE at different locations, - Different methods of specimen retrieval, Scott Young (USA) Francisco Carmona (Spain) - Interpretation of MRI for DIE, - Laparoscopic myomectomy for large fibroids, Anne-Elodie Millischer (France) Masaaki Andou (Japan) - Imaging modalities for adenomyosis - Questions & answers (2D TVS, 3D TVS, MRI), Giuliano Borrelli (Brazil) 10:40 Coffee break - Questions & answers - Surgical treatment of adenomyosis / adenomyoma: 15:20 Coffee break tips and tricks, Yoshiaki Ota (Japan) - Use of imaging to guide surgical approach (US), - Video masterclass: laparoscopic hysterectomy Juan L. Salgado (Puerto Rico) for huge fibroids, Masaaki Andou (Japan) - Use of imaging to guide surgical approach (MRI), - Video masterclass: tips and tricks on how to manage Kathy Huang (USA) multiple myomas, Wachyu Hadisaputra (Indonesia) - Use of Imaging for surveillance of endometriosis, - Video masterclass: hysteroscopic resection, Mauricio Abrao (Brazil) Peng-Hui Wang (Taiwan) Live scanning demonstration - Video masterclass: tips & tricks, Chair: Rosanne M. Kho (USA) Francisco Carmona (Spain) - Live scanning, Scott Young (USA) - Questions & answers 16:30 Welcome desk opening at SUNTEC 13:00 Lunch 18:00 Onsite registration 14:00 Myomectomy hands-on session SUNTEC and receipt of badges.
Recommended publications
  • Transplantation and Immunology 1
    Transplantation and Immunology 1 Transplantation and Immunology บรรยายโดย อ.นพ.สมชัย ลิ้มศรีจ าเริญ เรียบเรียง นพ.กิตติ์รวี จิรธานีเรืองกิจ อาจารย์ที่ปรึกษา อ.นพ.ราวิน วงษ์สถาปนาเลิศ Outline 1. Immunology 2. Immunosuppression: drug use in transplantation 3. Clinical transplant: liver pancreas intestine and kidney transplant ในอเมริกา ท า Transplant เยอะมาก และ resident ศัลยกรรมทุกคนต้องผ่าน rotation transplant ดังนั้น ในอนาคต บ้านเรา จะท ากันมากขึ้น และอาจจะบรรจุ เป็น requirement ให้ resident ต้องผ่าน • Immunology ประวัติศาสตร์ เริ่มจาก Jensen reported in 1902 - มีการทดลอง ศึกษาเกี่ยวกับ tumor และ immunology ของ tumor พบว่า สามารถน าเอา tumor จากหนูไป transplant ให้ตัวอื่นได้ ( ท าใน 19 successive generation) - พบว่าหนูบางส่วนจะ reject tumor ไม่ให้เติบโต (50% of mice) - โดยจะ reject ทุกครั้ง ที่น า tumor มา transplant ใหม่ (มี resistant to subsequent challenge) และ หากน า เอา normal tissue ใส่ไปก่อน และเอา tumor มา transplant ก็จะ reject ได้เร็วขึ้น - เกิด Theory อธิบายเหตุการณ์นี้ คือ Athrepsia theory (เกี่ยวกับ nutrition) เพราะ เวลาใส่ tumor เข้าไปแรกๆ จะยังเจริญได้ช่วงหนึ่งจากนั้น จึงตายไป เชื่อว่าเกิดจากการขาด สารอาหาร หลังจาก tumor ใช้สารอาหารหมด มันก็จะตายไป นับเป็นจุดเริ่มต้นที่ใช้ tumor ในการศึกษาหลักการเรื่อง Transplantation Medawar reported in 1943 (Nobel prize) - เมื่อมี rejection เกิดขึ้น หากเราใช้ graft ครั้งที่ 2 จาก donor เดิม จะเกิดการ reject เร็วขึ้น ซึ่งคิดว่าเกิดจาก Actively acquired immune reaction จากนั้นมีการศึกษาอีกหลายอย่างเพื่อศึกษา transplant immunology Owen reported in 1947 - ถ้าน าสัตว์เช่น ลูกวัว ที่เป็น dizygotic
    [Show full text]
  • Areas of Future Research in Fibroid Therapy
    9/18/18 Cumulative Incidence of Fibroids over Reproductive Lifespan RFTS Areas of Future Research Blacks Blacks UFS Whites in Fibroid Therapy CARDIA Age 33-46 William H. Catherino, MD, PhD Whites Professor and Chair, Research Division Seveso Italy Uniformed Services University Blacks Whites Associate Program Director Sweden/Whites (Age 33-40) Division of REI, PRAE, NICHD, NIH The views expressed in this article are those of the author(s) and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government. Laughlin Seminars Reprod Med 2010;28: 214 Fibroids Increase Miscarriage Rate Obstetric Complications of Fibroids Complication Fibroid No Fibroid OR Abnormal labor 49.6% 22.6% 2.2 Cesarean Section 46.2% 23.5% 2.0 Preterm delivery 13.8% 10.7% 1.5 BreecH position 9.3% 4.0% 1.6 pp Hemorrhage 8.3% 2.9% 2.2 PROM 4.2% 2.5% 1.5 Placenta previa 1.7% 0.7% 2.0 Abruption 1.4% 0.7% 2.3 Guben Reprod Biol Odds of miscarriage decreased with no myoma comparedEndocrinol to myoma 2013;11:102 Biderman-Madar ArcH Gynecol Obstet 2005;272:218 Ciavattini J Matern Fetal Neonatal Med 2015;28:484-8 Not Impacting the Cavity Coronado Obstet Gynecol 2000;95:764 Kramer Am J Obstet Gynecol 2013;209:449.e1-7 Navid Ayub Med Coll Abbottabad 2012;24:90 Sheiner J Reprod Med 2004;49:182 OR = 0.737 [0.647, 0.840] Stout Obstet Gynecol 2010;116:1056 Qidwai Obstet Gynecol 2006;107:376 1 9/18/18 Best Studied Therapies Hysterectomy Option over Time Surgical Radiologic Medical >100 years of study Hysterectomy Open myomectomy GnRH agonists 25-34 years of study Endometrial Ablation GnRH agonists 20-24 years of study Laparoscopic myomectomy Uterine artery embolization Retinoic acid 10-19 years of study Uterine artery obstruction SPRMs: Mifepristone, ulipristal Robotic myomectomy GnRH antagonists 5-9 years of study Cryomyolysis MRI-guided high frequency ultrasound SPRMs: Asoprisnil, Telapristone, Laparoscopic ablation Vilaprisan SERMs: Tamoxifen, Raloxifene, Letrozole, Genistein Pitter MC, Simmonds C, Seshadri-Kreaden U, Hubert HB.
    [Show full text]
  • Durham E-Theses
    Durham E-Theses Elemental Fluorine for the Greener Synthesis of Life-Science Building Blocks HARSANYI, ANTAL How to cite: HARSANYI, ANTAL (2016) Elemental Fluorine for the Greener Synthesis of Life-Science Building Blocks, Durham theses, Durham University. Available at Durham E-Theses Online: http://etheses.dur.ac.uk/11705/ Use policy The full-text may be used and/or reproduced, and given to third parties in any format or medium, without prior permission or charge, for personal research or study, educational, or not-for-prot purposes provided that: • a full bibliographic reference is made to the original source • a link is made to the metadata record in Durham E-Theses • the full-text is not changed in any way The full-text must not be sold in any format or medium without the formal permission of the copyright holders. Please consult the full Durham E-Theses policy for further details. Academic Support Oce, Durham University, University Oce, Old Elvet, Durham DH1 3HP e-mail: [email protected] Tel: +44 0191 334 6107 http://etheses.dur.ac.uk 2 Durham University A thesis entitled Elemental Fluorine for the Greener Synthesis of Life-Science Building Blocks by Antal Harsanyi (College of St. Hild and St. Bede) A candidate for the degree of Doctor of Philosophy Department of Chemistry, Durham University 2016 Antal Harsanyi: Elemental fluorine for the greener synthesis of life-science building blocks Abstract Fluorinated organic compounds are increasingly important in many areas of our modern lives, especially in pharmaceutical and agrochemical applications where the incorporation of this element can have a major influence on biochemical properties.
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • EC313-A Tissue Selective SPRM Reduces the Growth and Proliferation of Uterine Fbroids in a Human Uterine Fbroid Tissue Xenograft Model Hareesh B
    www.nature.com/scientificreports OPEN EC313-a tissue selective SPRM reduces the growth and proliferation of uterine fbroids in a human uterine fbroid tissue xenograft model Hareesh B. Nair1*, Bindu Santhamma1, Kalarickal V. Dileep2, Peter Binkley3, Kirk Acosta1, Kam Y. J. Zhang 2, Robert Schenken3 & Klaus Nickisch1 Uterine fbroids (UFs) are associated with irregular or excessive uterine bleeding, pelvic pain or pressure, or infertility. Ovarian steroid hormones support the growth and maintenance of UFs. Ulipristal acetate (UPA) a selective progesterone receptor (PR) modulator (SPRM) reduce the size of UFs, inhibit ovulation and lead to amenorrhea. Recent liver toxicity concerns with UPA, diminished enthusiasm for its use and reinstate the critical need for a safe, efcacious SPRM to treat UFs. In the current study, we evaluated the efcacy of new SPRM, EC313, for the treatment for UFs using a NOD-SCID mouse model. EC313 treatment resulted in a dose-dependent reduction in the fbroid xenograft weight (p < 0.01). Estradiol (E2) induced proliferation was blocked signifcantly in EC313-treated xenograft fbroids (p < 0.0001). Uterine weight was reduced by EC313 treatment compared to UPA treatment. ER and PR were reduced in EC313-treated groups compared to controls (p < 0.001) and UPA treatments (p < 0.01). UF specifc desmin and collagen were markedly reduced with EC313 treatment. The partial PR agonism and no signs of unopposed estrogenicity makes EC313 a candidate for the long-term treatment for UFs. Docking studies have provided a structure based explanation for the SPRM activity of EC313. Te unmet need for medical management of uterine fbroids (UFs) has led to the discovery of various novel agents in recent years.
    [Show full text]
  • Clinical Study Protocol M12-815 a Phase 3 Study to Evaluate The
    NCT02654054 Elagolix (ABT-620) M12-815 Protocol Amendment 3 1.0 Title Page Clinical Study Protocol M12-815 A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women Incorporating Amendments 1, 2 and 3 AbbVie Investigational Product: Elagolix (ABT-620) Date: 25 September 2017 Development Phase: 3 Study Design: Phase 3, randomized, double-blind, multicenter, placebo-controlled study evaluating the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women 18 to 51 years of age. Investigators: Multicenter Trial: Investigator information is on file at AbbVie Sponsor: AbbVie Sponsor/Emergency Contact: This study will be conducted in compliance with the protocol, Good Clinical Practice and all other applicable regulatory requirements, including the archiving of essential documents. Confidential Information No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie. 1 Elagolix (ABT-620) M12-815 Protocol Amendment 3 1.1 Protocol Amendment: Summary of Changes Previous Protocol Versions Protocol Date Original 06 November 2015 Amendment 1 01 December 2015 Amendment 2 23 June 2016 The purpose of this Amendment is to: ● Update Section 1.1 Protocol Amendment: Summary of Changes from Appendix Q to Appendix
    [Show full text]
  • (Ulipristal Acetate)-Treated Uterine Fibroids
    Journal of Clinical Medicine Article Markers of Inflammation and Vascular Parameters in Selective Progesterone Receptor Modulator (Ulipristal Acetate)-Treated Uterine Fibroids Iwona Szydłowska 1,* , Marta Grabowska 2,* , Jolanta Nawrocka-Rutkowska 1, Andrzej Kram 3, Małgorzata Piasecka 2 and Andrzej Starczewski 1 1 Department of Gynecology, Endocrinology and Gynecological Oncology, Pomeranian Medical University in Szczecin, Unii Lubelskiej 1 Street, 71-252 Szczecin, Poland; [email protected] (J.N.-R.); [email protected] (A.S.) 2 Department of Histology and Developmental Biology, Pomeranian Medical University, Zołnierska˙ 48 Street, 71-210 Szczecin, Poland; [email protected] 3 Department of Pathology, West Pomeranian Oncology Center, Strzałowska 22 Street, 71-730 Szczecin, Poland; [email protected] * Correspondence: [email protected] (I.S.); [email protected] (M.G.); Tel.: +48-91-425-0541 (I.S.) Abstract: The exact mechanism of selective progesterone receptor modulator action in leiomyoma still challenges researchers. The aim of the study was to assess the effects of ulipristal acetate (UPA) on immunoexpression of inflammatory markers and vascularization in fibroids. UPA-treated patients were divided into three groups: (1) good response (≥25% reduction in volume of fibroid), (2) weak response (insignificant volume reduction), (3) and no response to treatment (no decrease or increase in fibroid volume). The percentage of TGFβ, IL6, IL10, CD117, and CD68-positive cells were Citation: Szydłowska, I.; Grabowska, significantly lower in the group with a good response to treatment vs. the control group. Moreover, M.; Nawrocka-Rutkowska, J.; Kram, the percentage of IL10 and CD68-positive cells in the group with a good response to treatment were A.; Piasecka, M.; Starczewski, A.
    [Show full text]
  • Selective Progesterone Receptor Modulators in Gynaecological Therapies
    65 1 Journal of Molecular H O D Critchley and SPRMs in gynaecological 65:1 T15–T33 Endocrinology R Chodankar therapies THEMATIC REVIEW 90 YEARS OF PROGESTERONE Selective progesterone receptor modulators in gynaecological therapies H O D Critchley and R R Chodankar MRC Centre for Reproductive Health, The University of Edinburgh, The Queen’s Medical Research Institute, Edinburgh Bioquarter, Edinburgh, UK Correspondence should be addressed to H O D Critchley: [email protected] This review forms part of a special section on 90 years of progesterone. The guest editors for this section are Dr Simak Ali, Imperial College London, UK, and Dr Bert W O’Malley, Baylor College of Medicine, USA. Abstract Abnormal uterine bleeding (AUB) is a chronic, debilitating and common condition Key Words affecting one in four women of reproductive age. Current treatments (conservative, f abnormal uterine medical and surgical) may be unsuitable, poorly tolerated or may result in loss of fertility. bleeding (AUB) Selective progesterone receptor modulators (SPRMs) influence progesterone-regulated f heavy menstrual bleeding (HMB) pathways, a hormone critical to female reproductive health and disease; therefore, f selective progesterone SPRMs hold great potential in fulfilling an unmet need in managing gynaecological receptor modulators disorders. SPRMs in current clinical use include RU486 (mifepristone), which is licensed (SPRM) for pregnancy interruption, and CDB-2914 (ulipristal acetate), licensed for managing AUB f leiomyoma in women with leiomyomas and in a higher dose as an emergency contraceptive. In this f fibroid article, we explore the clinical journey of SPRMs and the need for further interrogation of this class of drugs with the ultimate goal of improving women’s quality of life.
    [Show full text]
  • Endometriosis and Women's Reproductive Life
    1ST CONGRESS OF THE SOCIETY OF ENDOMETRIOSIS AND UTERINE DISORDERS Endometriosis and women’s reproductive life 2015 MAY 7-8-9 Location Congress President Paris, France Pr Charles Chapron, Paris, France Marriott Rive Gauche Table of contents 4 WELCOME NOTE 5 BOARDS / FACULTIES AND INTERNATIONAL COMMITTEE 6 PROGRAM 24 SOCIAL PROGRAM 26 PARIS, A FABULOUS HERITAGE 28 PARTNERS Join a growing list of surgeons experiencing the unique functions of the PlasmaJet® Surgery System. Use Kinetic Dissection™ to help you visualize and dissect tissue planes and Microlayer Vaporization™ to enable you to perform more complete disease removal. Illustrated example of PlasmaJet being used to vaporize endometrial lesions in a controlled fashion. © Copyright 2015 Plasma Surgical. All rights reserved. Respect for Tissue. 3 Welcome to Paris Board Dear friends and colleagues, CONGRESS PRESIDENT : ORGANIZING COMMITTEE Charles Chapron, France Bruno Borghese, On behalf of the scientific board and the organizing committee, I am honored to wel- Vanessa Gayet come you in Paris for the first congress of the “Society of Endometriosis and Uterine Arnaud Le Tohic, Disorders” (SEUD). Louis Marcellin, Pierre Panel, The aim of SEUD is to offer an international scientific platform for giving the possibility Pietro Santulli, to have a comprehensive approach of womens’ health in the field of benign gynecolo- Dominique de Ziegler gical diseases related to uterine dysfunctions. The objective of the SEUD is to focus the attention on a group of benign gynecological diseases which affect womens’ health (en- dometriosis, adenomyosis, uterine fibroids, polyps, heavy menstrual bleeeding, uterine malformations and others). Faculties and The congress has been designed to provide an innovative and comprehensive overview of the latest research developments in endometriosis, in uterine disorders and in wo- international committee men’s reproductive life fields.
    [Show full text]
  • Laparoscopic Myomectomy
    Future Directions for the Treatment of Leiomyomas WILLIAM H. CATHERINO, MD, PHD PROFESSOR AND CHAIR-RESEARCH, DEPARTMENT OF OBSTETRICS AND GYNECOLOGY UNIFORMED SERVICES UNIVERSITY NATIONAL INSTITUTES OF HEALTH Objectives At the completion of this lecture, you will: u Understand the benefits and drawbacks of surgical intervention u Understand the benefits and drawbacks of minimally invasive interventions u Understand the benefits and drawbacks of medical interventions Please email [email protected] with any ?s Disclosures u Consultant: Abbvie, Allergan, Bayer u Research grant: Allergan u Wife, Scientific Director: EMD Serono Please email [email protected] with any ?s Best Studied Therapies for Fibroids Surgical Radiologic Medical ______ >100 years of study Hysterectomy Open myomectomy GnRH agonists 25-34 years of study SERMs: Tamoxifen Endometrial Ablation GnRH agonists 20-24 years of study SERMs: Raloxifene Laparoscopic myomectomy Uterine artery embolization Retinoic acid 10-19 years of study SERMs: Letrozole, genestein Uterine artery obstruction SPRMs: Mifepristone, asoprisnil, ulipristal Robotic myomectomy GnRH antagonists 5-9 years of study Cryomyolysis MRI-guided high frequency u/s SPRMs: Telepristone Laparoscopic ablation Please email [email protected] with any ?s Surgical Intervention Scientific Study Into Various Fibroid Treatments Minimally Invasive Surgical Interventions Interventions Medical Interventions 180 80 20 135 60 15 90 40 10 45 20 5 0 2008 2010 2012 2014 2016 0 0 2008 2010 2012 2014 2016 20082009 2010201120122013 201420152016 hysterectomy Laparoscopic myomectomy UAE Ulipristal Leuprolide Hysteroscopic myomectomy Endometrial ablation Mifepristone Levonorgestrel Open myomectomy Radiofrequency ablation Letrozole Cetrorelix Robotic myomectomy MRI-Guided HiFU Triptorelin Vilaprisan Hysterectomy Decreasing Over Time Please email [email protected] with any ?s Laparoscopic Myomectomy • Shorter inpatient stay (52hrs vs.
    [Show full text]
  • WO 2018/060501 A2 05 April 2018 (05.04.2018) W ! P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/060501 A2 05 April 2018 (05.04.2018) W ! P O PCT (51) International Patent Classification: (71) Applicants: MYOVANT SCIENCES GMBH [CH/CH]; A61K 31/513 (2006.01) Viaduktstrasse 8, 405 1 Basel (CH). TAKEDA PHAR¬ MACEUTICAL COMPANY LIMITED [JP/JP]; 1-1, (21) International Application Number: Doshomachi 4-chome, Chuo-ku, Osaka-shi, Osaka, PCT/EP20 17/074907 541-0045 (JP). (22) International Filing Date: (72) Inventors: JOHNSON, Brendan Mark; 2017 Markham 29 September 2017 (29.09.2017) Drive, Chapel Hill, 275 14 (NC). SEELY, Lynn; 537 Occi (25) Filing Language: English dental Avenue, San Mateo, 94402 (US). MUDD, JR., Paul N.; 302 Beacon Falls Court, Cary, North Carolina 27519 (26) Publication Langi English (US). WOLLOWITZ, Susan; 32 Topper Court, Lafayette, (30) Priority Data: California 94549 (US). HIBBERD, Mark; The Old House, 62/402,034 30 September 2016 (30.09.2016) US Hawkley, Liss Hampshire GU33 6NQ (GB). TANIMO- 62/402,055 30 September 2016 (30.09.2016) US TO, Masataka; c/o Takeda Pharmaceutical Company Lim 62/402,150 30 September 2016 (30.09.2016) US ited, 1-1, Doshomachi 4-chome, Chuo-ku, Osaka-shi, O sa 62/492,839 0 1 May 2017 (01 .05.2017) US ka, 541-0045 (JP). RAJASEKHAR, Vijaykumar Reddy; 62/528,409 03 July 2017 (03.07.2017) US 20200 Quail Hollow Road, Apple Valley, California 92308 (54) Title: METHODS OF TREATING UTERINE FIBROIDS AND ENDOMETRIOSIS PBAC=0 Lumbar BMD CD n co CD P g CO O O CD Dose (mg) FIG.
    [Show full text]
  • News Release 51368 Leverkusen Germany Tel
    Bayer AG Communications and Public Affairs News Release 51368 Leverkusen Germany Tel. +49 214 30-0 Not intended for U.S. and UK Media www.news.bayer.com Bayer starts Phase III study program with Vilaprisan in the treatment of symptomatic uterine fibroids Berlin, July 3, 2017 – Bayer announced today that the first patient was enrolled in a Phase III clinical study program ASTEROID which will investigate vilaprisan in women suffering from uterine fibroids. Vilaprisan, discovered at Bayer, is a novel oral, selective progesterone receptor modulator (SPRM) which may allow for effective long-term treatment of uterine fibroids. Uterine fibroids are the most common benign gynaecological tumors of women of reproductive age. They are frequently characterised by heavy menstrual bleeding, pain and bulk symptoms. Uterine fibroids are a leading cause of hysterectomy (removal of the uterus) and their impact on a woman’s life can be significant. Approximately 5–10% of women of reproductive age have symptoms of uterine fibroids and require treatment. “Based on the promising results we have seen with vilaprisan in the Phase II clinical study program, we are very excited about the start of the Phase III trials that aims for a new symptom control for symptomatic uterine fibroids in a long-term treatment option. While this condition impacts women in their everyday life, current medical treatment options are not satisfactory,” said Dr Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Development. “It is our ambitious goal that our research efforts in this field result in a medical therapy that controls symptoms and thereby significantly improves the quality of life for women with uterine fibroids.” The planned ASTEROID Phase III clinical study program will include several studies to investigate the efficacy and safety of vilaprisan 2mg in patients with symptomatic uterine fibroids.
    [Show full text]