Jacques Donnez1, Francisco Vázquez2, Janusz Tomaszewski3, Kazem Nouri4, Philippe Bouchard5, Bart C J M Fauser6, David H Barlow7, Santiago Palacios8, Olivier Donnez9, Elke Bestel10, Ian Osterloh11, Ernest Loumaye12. 1. Société de Recherche pour l'Infertilité, Brussels, Belgium. Electronic address: jacques.donnez@gmail.com. 2. Centro de Estudios de Obstetricia y Ginecología Asociado, Lugo, Spain. 3. Prywatna Klinika Polozniczo-Ginekologiczna, Bialystok, Poland. 4. Department of Gynecological Endocrinology and Reproductive Medicine, Medical School of Vienna, Vienna, Austria. 5. Endocrinology Unit, AP-HP Hospital Saint-Antoine, Paris, France. 6. Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands. 7. College of Medical, Veterinary, and Life Sciences, University of Glasgow, Glasgow, Scotland. 8. Palacios' Institute of Women's Health, Madrid, Spain. 9. Centre Hospitalier Universitaire Université Catholique de Louvain Mont-Godinne Dinant, Yvoir, Belgium. 10. PregLem S.A., Geneva, Switzerland. 11. OsterMed Ltd., Birmingham, United Kingdom. 12. ObsEva S.A. Geneva, Switzerland.
Abstract
OBJECTIVE: To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids. DESIGN: Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo. SETTING:European clinical gynecology centers. PATIENT(S): Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding. INTERVENTION(S): Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo. MAIN OUTCOME MEASURE(S): Amenorrhea, fibroid volume, endometrial histology. RESULT(S): After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2-6 days). Median fibroid volume change was -45% (interquartile range, -66%; -25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were -63%, -67%, and -72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology. CONCLUSION(S): Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).
RCT Entities:
OBJECTIVE: To investigate the efficacy and safety of ulipristal acetate (UPA) for long-term treatment of symptomatic uterine fibroids. DESIGN: Repeated intermittent open-label UPA courses, each followed by randomized double-blind norethisterone acetate (NETA) or placebo. SETTING: European clinical gynecology centers. PATIENT(S): Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding. INTERVENTION(S): Patients received up to four 3-month courses of UPA 10 mg daily, immediately followed by 10-day double-blind treatment with NETA (10 mg daily) or placebo. MAIN OUTCOME MEASURE(S): Amenorrhea, fibroid volume, endometrial histology. RESULT(S): After the first UPA course, amenorrhea occurred in 79% of women, with median onset (from treatment start) of 4 days (interquartile range, 2-6 days). Median fibroid volume change was -45% (interquartile range, -66%; -25%). Amenorrhea rates were 89%, 88%, and 90% for the 131, 119, and 107 women who received treatment courses 2, 3, and 4, respectively. Median times to amenorrhea were 2, 3, and 3 days for treatment courses 2, 3, and 4, respectively. Median fibroid volume changes from baseline were -63%, -67%, and -72% after treatment courses 2, 3, and 4, respectively. All endometrial biopsies showed benign histology without hyperplasia; NETA did not affect fibroid volume or endometrial histology. CONCLUSION(S): Repeated 3-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (www.clinicaltrials.gov) registration numbers NCT01156857 (PEARL III) and NCT01252069 (PEARL III extension).
Authors: James A Simon; William Catherino; James H Segars; Rick E Blakesley; Anna Chan; Vilma Sniukiene; Ayman Al-Hendy Journal: Obstet Gynecol Date: 2018-03 Impact factor: 7.661
Authors: Nichole M Barker; David A Carrino; Arnold I Caplan; William W Hurd; James H Liu; Huiqing Tan; Sam Mesiano Journal: Reprod Sci Date: 2015-09-29 Impact factor: 3.060