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Fertility & Sterility® POSTER SESSION: LATE-BREAKING ABSTRACTS P-931 3:30 PM Wednesday, October 21, 2020 LINZAGOLIX MAY ADDRESS THE LONG-TERM P-930 3:30 PM Wednesday, October 21, 2020 TREATMENT NEEDS OF WOMEN WITH UTERINE FI- BROIDS (UF) WHO HAVE CONTRAINDICATIONS TO EFFICACYAND SAFETY OF LINZAGOLIX (LGX) FOR HORMONAL ADD-BACK THERAPY (ABT): RESULTS THE TREATMENT OF HEAVY MENSTRUAL FROM TWO PHASE 3 RANDOMIZED CLINICAL BLEEDING (HMB) DUE TO UTERINE FIBROIDS TRIALS. Linda D. Bradley, MD,1 Erica E. Marsh, MD, MSCI, FACOG,2 (UF): RESULTS FROM TWO PHASE 3 RANDOMIZED Elizabeth Garner, MD, MPH.3 1Cleveland Clinic Cleveland, OH; 2University CLINICAL TRIALS. Elizabeth A. Stewart, MD,1 Hugh S. Taylor, of Michigan, Ann Arbor, MI; 3ObsEva Inc, Boston, MA. MD,2 Robert N. Taylor, MD, PhD,3 Jacques Donnez, PhD, MD,4 Elke Bestel, MD,5 Jean-Pierre Gotteland, PhD,5 Andrew Humberstone, OBJECTIVE: GnRH antagonists comprise a new class of orally active med- PhD,5 Elizabeth Garner, MD, MPH.6 1Mayo Clinic Department of OB/ ications that dose-dependently reduce estradiol (E2) levels, allowing partial sup- GYN Reproductive Endocrinology and Infertility, Rochester, MN; 2Yale pression for symptom relief of estrogen-driven conditions without the bone University School of Medicine, New Haven, CT; 3University of Utah Health, (BMD) loss seen with full suppression. A GnRH antagonist developed using a Salt Lake City, UT; 4Polyclinique Urbain V (ELSAN Group), Brussels, full suppression dose that requires use of hormonal ABT was recently approved Belgium; 5ObsEva SA, Plan-les-Ouates, Switzerland; 6ObsEva Inc, Boston, for the treatment of UF. Its labeling lists obesity, hypertension, and dyslipidemia MA. as ABT contraindications associated with higher risks of thrombotic, stroke and cardiac events, which disproportionately affect black women. Given the propen- OBJECTIVE: To assess the efficacy and safety of LGX, an oral GnRH re- sity of black women to develop severe UF, availability of a GnRH antagonist that ceptor antagonist, administered with and without hormonal add-back therapy can be used long-term without ABT is important. (ABT: 1 mg estradiol/0.5 mg norethindrone acetate), for the treatment of Linzagolix (LGX) is a GnRH antagonist being developed for UF treat- HMB and other symptoms of UF. ment. In addition to a high dose (200 mg) with ABT (1 mg E2/0.5 mg DESIGN: PRIMROSE 1 (USA, n¼526) and PRIMROSE 2 (Europe NETA), a low dose (100 mg) without (w/o) ABT is being assessed as a po- and USA, n¼511) are randomized, double-blind, placebo-controlled tential long-term treatment option for women with ABT contraindications. Phase 3 trials, with essentially identical design, investigating the effi- DESIGN: PRIMROSE 1 (P1; US, n¼526) and PRIMROSE 2 (P2; Europe/ cacy and safety of LGX Æ ABT once daily for 52 weeks. We report US, n¼511) are randomized, double-blind, placebo-controlled Phase 3 trials results up to 24-weeks for PRIMROSE 1 and up to 52-weeks for PRIM- investigating the efficacy and safety of LGX 100 mg and 200 mg once daily, ROSE 2. with and w/o ABT. Here we present results from 24 weeks (wks) (P1 and P2) MATERIALS AND METHODS: Participants had HMB (> 80 mL and 52 wks of treatment (P2) with the 100 mg dose w/o ABT. menstrual blood loss [MBL]/cycle) due to UF and excluded if they MATERIALS AND METHODS: Inclusion criteria included having UF had significant risk of osteoporosis. Subjects were randomized to 1 and Heavy Menstrual Bleeding (HMB) (> 80 mL menstrual blood loss of 5 treatments: placebo, LGX 100 mg, LGX 100 mg + ABT, LGX [MBL]/cycle). The primary endpoint was HMB reduction defined as % 80 200 mg, LGX 200 mg + ABT. PRIMROSE 2 subjects randomized to mL MBL (by alkaline hematin method) and R 50% reduction at wk 24. Sec- placebo or LGX 200 mg were crossed-over to 200 mg LGX + ABT af- ondary endpoints included amenorrhea, hemoglobin (Hb), pain, and quality ter 24 weeks. of life (QoL). Safety endpoints included BMD and adverse events (AEs). The primary efficacy endpoint was reduction in alkaline-hematin Calcium/vitamin D were not provided. documented HMB to % 80 mL MBL and a reduction of R 50% at RESULTS: The 100 mg w/o ABT dose was studied in 191 women, 64% 24 weeks. Secondary endpoints included amenorrhea, time to reduced (P1) and 4% (P2) of whom were black; results were similar across the studies. MBL/amenorrhea, days of uterine bleeding, hemoglobin, pain, uterine P1 and P2 responder rates (RRs) were statistically significantly better than and fibroid volume and quality of life. Safety endpoints included bone pbo, at 56.4% (p¼0.003) and 56.7% (p%0.001), respectively, with an RR mineral density (BMD) assessed centrally using Dual Energy X-ray of 53.2% in P2 at wk 52. Amenorrhea rates were 34.0% (p<0.001) and Absorptiometry and adverse events (AE). Calcium/vitamin D were 38.3% (p¼0.009), respectively, and in P2 at 52 wks, 39.2%. MBL reduction not provided nor recommended in the trials. was rapid, with 60% mean % change from baseline within the first 4 wks of Individual active vs placebo efficacy comparisons were conducted using a treatment. Statistically significant improvements in pain, Hb levels and QoL 0.0125 significance level to account for multiplicity. were also observed. RESULTS: PRIMROSE 1 subjects had a mean age of 42 years and 63% Week 24 mean % BMD changes were -2.0% [95% CI: -3.3, -0.8] and were Black. The mean baseline MBL was 199 mL. HMB at week 24 was -2.1% [95% CI: -2.6, -1.5] for P1 and P2, respectively, with additional significantly (p%0.003) reduced in all active treatment groups compared -0.3% mean change at wk 52 in P2. AEs occurring in > 5% of women to placebo. Responder rates were 35, 56, 67, 71 and 75% in the placebo, were hot flushes (6.0%/14.1%; pbo: 6.7%/3.8%), headache (8.0%/4.0%; 100 mg, 100 mg + ABT, 200 mg and 200 mg + ABT groups, respectively. pbo 5.8%/5.7%), and anemia (1.0%/19.2%; pbo: 3.8%/10.5%) in P1 and PRIMROSE 2 subjects had a mean age of 43 years and 5% were Black. P2, respectively. In the 100 mg w/o ABT arm, one drug-related serious AE The mean baseline MBL was 218 mL. HMB at week 24 was significantly (hypertension) (HTN) was observed. (p<0.001) reduced in all active treatment groups compared to placebo. CONCLUSIONS: LGX 100 mg w/o ABT significantly improved HMB Responder rates were 29, 57, 77, 78 and 94% in the respective groups, and and other UF symptoms, with low AE rates and minimal associated BMD were maintained at 52 weeks. loss that showed evidence of plateauing after 24 wks. This regimen has the In both trials, significant improvements compared to placebo were unique potential to address the needs of black women with UF, many of observed for key secondary endpoints, including pain and QoL, at whom have ABT contraindications. week 24. Mean % loss in BMD ranged from 0–2% after 24 weeks in all active treatment groups except 200 mg LGX without ABT (3–4%). The rate of BMD loss slowed between weeks 24 and 52. The most com- P-932 3:30 PM Wednesday, October 21, 2020 mon AE, hot flushes, were reported in 32–35% of subjects in the LGX 200 mg without ABT group and less than 15% in the other active treat- IS COVID-19 A SEXUALLY TRANSMITTED DISEASE? ment groups at week 24. A SYSTEMATIC REVIEW. Tomer Tur-Kaspa, CONCLUSIONS: Once daily LGX 100 and 200 mg, both with or without Grace Hildebrand, BA, David Cohen, MD, Ilan Tur-Kaspa, ABT significantly improved HMB and other symptoms of uterine fibroids at MD. Institute for Human Reproduction (IHR) Chicago, IL. 24 weeks and these improvements were maintained at 52 weeks. An effective OBJECTIVE: SARS-CoV-2 has led to a rapidly spreading COVID-19 GnRH antagonist treatment without hormonal ABT could be important for global pandemic. From a public health perspective, it is crucial to determine up to 50% of patients who may have contraindications to hormonal ABT. if SARS-CoV-2 is sexually transmitted and its possible effects on human Limited BMD loss in the LGX 200 mg with ABT and LGX 100 mg without reproduction. ABT arms suggests these dosing regimens could be suitable for longer-term DESIGN: A systematic review of English publications to July 15, 2020, treatment. was conducted according to PRISMA guidelines. A search in PubMed, SUPPORT: The work was funded by ObsEva SA. NIH iCite COVID-19 portfolio, Cochrane Library, and Google Scholar FERTILITY & STERILITYÒ e527 databases was conducted for SARS-CoV-2 and COVID-19 with fertility, frozen cycles, respectively, while 73.6% reported a R75% IUI case reduc- reproduction, testes, seminal, prostatic and vaginal fluids, and in cervical tion. 3.7% of clinics reported no reduction in case volume. smears. The focus of this review is sexual transmission by vaginal inter- Among clinics that stopped or reduced services, 69.5% cited government- course. Fecal-oral transmission has been discussed by others. mandate as a reason for closing, 31.1% due to employer concern for the MATERIALS AND METHODS: The search revealed 1,107 publications health and safety of staff, 35.4% due to patient concerns, and 34% due to con- after removal of duplicates, which were reviewed for eligibility by examining cerns regarding possible effects of COVID-19 on pregnancy. Lack of PPE titles and abstracts. 141 full-text articles were reviewed and evaluated by two was only acknowledged by 5.3% as a reason for closure.
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