Jacques Donnez1, Robert Hudecek2, Olivier Donnez3, Dace Matule4, Hans-Joachim Arhendt5, Janos Zatik6, Zaneta Kasilovskiene7, Mihai Cristian Dumitrascu8, Hervé Fernandez9, David H Barlow10, Philippe Bouchard11, Bart C J M Fauser12, Elke Bestel13, Paul Terrill14, Ian Osterloh15, Ernest Loumaye16. 1. Société de Recherche pour l'infertilité, Brussels, Belgium. Electronic address: jacques.donnez@gmail.com. 2. Department of Obstetrics and Gynaecology, Masaryk University and University Hospital Brno, Brno, Czech Republic. 3. Institut de Recherche Expérimentale et Clinique (IREC), Université de Louvain, Centre Hospitalier Université (CHU) Université Catholique de Louvain (UCL) Mont-Godinne Dinant, Yvoir, Belgium. 4. Medical Company ARS Gynaecology, Department No.5, Riga, Latvia. 5. Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung, Magdeburg, Germany. 6. Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo, Debrecen, Hungary. 7. Private Clinic "Maxmeda" Vilnius, Lithuania. 8. Centrul Medical EUROMED SRL, Obstetrica-Ginecologie, Bucuresti, Romania. 9. Hôpital Bicêtre-Assistance Publique-Hopitaux de Paris (APHP), Service de Gynécologie-Obstétrique, Le Kremlin, Bicêtre cedex, France. 10. Hamad Medical Corporation, Women's Health Services, Qatar. 11. Service d'Endocrinologie, Hôpital Saint-Antoine, Paris, France. 12. Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands. 13. PregLem S.A., Plan-les-Ouates, Geneva, Switzerland. 14. CROS NT Limited, Maidenhead. 15. OsterMed Ltd., Birmingham, United Kingdom. 16. ObsEva SA, Plan-les-Ouates, Geneva, Switzerland.
Abstract
OBJECTIVE: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. DESIGN: Double-blind, randomized administration of two 12-week courses of ulipristal acetate. SETTING: Gynecology centers. PATIENT(S): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. INTERVENTION(S): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. MAIN OUTCOME MEASURE(S): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. RESULT(S): In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events. CONCLUSION(S): Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids. CLINICAL TRIAL REGISTRATION NUMBER: NCT01629563 (PEARL IV).
RCT Entities:
OBJECTIVE: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily of ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. DESIGN: Double-blind, randomized administration of two 12-week courses of ulipristal acetate. SETTING: Gynecology centers. PATIENT(S): A total of 451 patients with symptomatic uterine fibroid(s) and heavy bleeding. INTERVENTION(S): Two repeated 12-week treatment courses of daily 5 or 10 mg of ulipristal acetate. MAIN OUTCOME MEASURE(S): Amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), pain. RESULT(S): In the 5- and 10-mg treatment groups (62% and 73% of patients, respectively) achieved amenorrhea during both treatment courses. Proportions of patients achieving controlled bleeding during two treatment courses were >80%. Menstruation resumed after each treatment course and was diminished compared with baseline. After the second treatment course, median reductions from baseline in fibroid volume were 54% and 58% for the patients receiving 5 and 10 mg of ulipristal acetate, respectively. Pain and QoL improved in both groups. Ulipristal acetate was well tolerated with less than 5% of patients discontinuing treatment due to adverse events. CONCLUSION(S): Repeated 12-week courses of daily oral ulipristal acetate (5 and 10 mg) effectively control bleeding and pain, reduce fibroid volume, and restore QoL in patients with symptomatic fibroids. CLINICAL TRIAL REGISTRATION NUMBER: NCT01629563 (PEARL IV).
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