Is Covid-19 a Sexually Transmitted Disease? A Systematic Review

Abstract

OBJECTIVE: To assess the efficacy and safety of LGX, an oral GnRH receptor antagonist, administered with and without hormonal add-back therapy (ABT: 1 mg estradiol/0.5 mg norethindrone acetate), for the treatment of HMB and other symptoms of UF.DESIGN: PRIMROSE 1 (USA, n¼526) and PRIMROSE 2 (Europe and USA, n¼511) are randomized, double-blind, placebo-controlled Phase 3 trials, with essentially identical design, investigating the efficacy and safety of LGX AE ABT once daily for 52 weeks. We report results up to 24-weeks for PRIMROSE 1 and up to 52-weeks for PRIM-ROSE 2.MATERIALS AND METHODS: Participants had HMB (> 80 mL menstrual blood loss [MBL]/cycle) due to UF and excluded if they had significant risk of osteoporosis. Subjects were randomized to 1 of 5 treatments: placebo, LGX 100 mg, LGX 100 mg + ABT, LGX 200 mg, LGX 200 mg + ABT. PRIMROSE 2 subjects randomized to placebo or LGX 200 mg were crossed-over to 200 mg LGX + ABT after 24 weeks.The primary efficacy endpoint was reduction in alkaline-hematin documented HMB to % 80 mL MBL and a reduction of R 50% at 24 weeks. Secondary endpoints included amenorrhea, time to reduced MBL/amenorrhea, days of uterine bleeding, hemoglobin, pain, uterine and fibroid volume and quality of life. Safety endpoints included bone mineral density (BMD) assessed centrally using Dual Energy X-ray Absorptiometry and adverse events (AE). Calcium/vitamin D were not provided nor recommended in the trials.Individual active vs placebo efficacy comparisons were conducted using a 0.0125 significance level to account for multiplicity.RESULTS: PRIMROSE 1 subjects had a mean age of 42 years and 63% were Black. The mean baseline MBL was 199 mL. HMB at week 24 was significantly (p%0.003) reduced in all active treatment groups compared to placebo. Responder rates were 35, 56, 67, 71 and 75% in the placebo, 100 mg, 100 mg + ABT, 200 mg and 200 mg + ABT groups, respectively.PRIMROSE 2 subjects had a mean age of 43 years and 5% were Black. The mean baseline MBL was 218 mL. HMB at week 24 was significantly (p<0.001) reduced in all active treatment groups compared to placebo. Responder rates were 29, 57, 77, 78 and 94% in the respective groups, and were maintained at 52 weeks.In both trials, significant improvements compared to placebo were observed for key secondary endpoints, including pain and QoL, at 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 common 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 treatment groups at week 24.CONCLUSIONS: Once daily LGX 100 and 200 mg, both with or without ABT significantly improved HMB and other symptoms of uterine fibroids at 24 weeks and these improvements were maintained at 52 weeks. An effective GnRH antagonist treatment without hormonal ABT could be important for up to 50% of patients who may have contraindications to hormonal ABT. Limi...

Failure to Detect Viral RNA in Follicular Fluid Aspirates from a SARS-CoV-2-Positive Woman

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A Narrative Review of SARS-CoV-2 Pathogenesis, Transmission, and Clinical Manifestations

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