Objective: To evaluate the safety and efficacy of elagolix vs. placebo and elagolix with low-dose E/progestogen add-back therapy.
Design: Proof-of-concept, dose-ranging, multiple-cohort study.
Background: Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies.
Methods: We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain.
Fortified Bengal gram sattu was prepared following standardized sattu making procedure and fortified as per FDA using wheat flour with thiamin, riboflavin, niacin, Ca and Fe and stored at 25°C, 65% RH and 35°C, 65% RH and at ambient condition (16-39°C, 18-98% RH) in low density polyethylene and laminated aluminum foil pouches. Alcoholic acidity increased by 0.04% in different sattu samples during 180 days storage but was within the acceptable limit as per BIS standard.
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