Qi Yu1, Yingfang Zhou2, Larisa Suturina3,4, Unnop Jaisamrarn5, Dongmei Lu6, Susanne Parke7. 1. 1 Department of Obstetrics and Gynecology, Peking Union Medical College Hospital , Chinese Academy of Medical Science, Beijing, P.R. China . 2. 2 Department of Obstetrics and Gynecology, Peking University First Hospital , Beijing, China . 3. 3 Scientific Center for Family Health and Human Reproduction Problems , Irkutsk, Russia . 4. 4 Irkutsk State Medical Academy for Postgraduate Education , Irkutsk, Russia . 5. 5 Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University , Bangkok, Thailand . 6. 6 Pharmaceutical Statistics , Bayer Pharma AG, Beijing, China . 7. 7 Global Clinical Development Women's HealthCare, Bayer AG, Berlin, Germany .
Abstract
BACKGROUND: To investigate the efficacy and safety of estradiol valerate (EV)/dienogest (DNG) for the management of heavy menstrual bleeding (HMB) in Asian and non-Asian women desiring contraception. MATERIALS AND METHODS: In this multicenter, double-blind, phase III study, women were randomized 2:1 to receive EV/DNG or placebo tablets daily for seven 28-day cycles. The primary endpoint was the absolute change in menstrual blood loss (MBL) volume between the run-in and efficacy phases (90 days each). Secondary endpoints included the proportion of women with successful treatment (i.e., no episodes of MBL ≥80 mL and a decrease of <50% in MBL), percent change in MBL from the run-in phase, and change in hemoglobin and serum ferritin levels. Adverse events (AEs) were monitored throughout the study. RESULTS: Of the 341 women (mean age 34.7 ± 7.7 years; 309 Asians, 32 non-Asians) randomized, 270 completed the study. Mean reduction in MBL volume from run-in phase was significantly greater with EV/DNG than placebo (366.75 mL vs. 149.14 mL; p < 0.0001), with ∼52% and 12% of women, respectively, experiencing successful treatment. Percent decrease in MBL volume from the run-in phase was significantly greater with EV/DNG than placebo (63.5% vs. 24.8%; p < 0.0001). Hemoglobin and serum ferritin levels were increased with EV/DNG compared with placebo. Study drug-related AEs were reported in 16.3% and 8.2% of women with EV/DNG and placebo, respectively, none of which were of severe intensity. CONCLUSIONS:EV/DNG may be a safe and effective option in the treatment of HMB in Asian and non-Asian women who desire contraception.
RCT Entities:
BACKGROUND: To investigate the efficacy and safety of estradiol valerate (EV)/dienogest (DNG) for the management of heavy menstrual bleeding (HMB) in Asian and non-Asian women desiring contraception. MATERIALS AND METHODS: In this multicenter, double-blind, phase III study, women were randomized 2:1 to receive EV/DNG or placebo tablets daily for seven 28-day cycles. The primary endpoint was the absolute change in menstrual blood loss (MBL) volume between the run-in and efficacy phases (90 days each). Secondary endpoints included the proportion of women with successful treatment (i.e., no episodes of MBL ≥80 mL and a decrease of <50% in MBL), percent change in MBL from the run-in phase, and change in hemoglobin and serum ferritin levels. Adverse events (AEs) were monitored throughout the study. RESULTS: Of the 341 women (mean age 34.7 ± 7.7 years; 309 Asians, 32 non-Asians) randomized, 270 completed the study. Mean reduction in MBL volume from run-in phase was significantly greater with EV/DNG than placebo (366.75 mL vs. 149.14 mL; p < 0.0001), with ∼52% and 12% of women, respectively, experiencing successful treatment. Percent decrease in MBL volume from the run-in phase was significantly greater with EV/DNG than placebo (63.5% vs. 24.8%; p < 0.0001). Hemoglobin and serum ferritin levels were increased with EV/DNG compared with placebo. Study drug-related AEs were reported in 16.3% and 8.2% of women with EV/DNG and placebo, respectively, none of which were of severe intensity. CONCLUSIONS:EV/DNG may be a safe and effective option in the treatment of HMB in Asian and non-Asian women who desire contraception.
Entities:
Keywords:
combined oral contraceptive; dienogest; estradiol valerate; heavy menstrual bleeding; menstrual blood loss
Authors: Anne Lethaby; Michelle R Wise; Maria Aj Weterings; Magdalena Bofill Rodriguez; Julie Brown Journal: Cochrane Database Syst Rev Date: 2019-02-11