Trial reportClinical pharmacology in drug development2026
Bioequivalence of a Fixed-Dose Combination of Relugolix, Estradiol, and Norethindrone Acetate: An Open-Label, Randomized, Fully Replicate Crossover Study in Healthy Postmenopausal Women Under Fasting Conditions.
Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
Uterine fibroids are the most common benign gynecological tumors, often causing heavy menstrual bleeding (HMB), anemia, and impaired quality of life. A fixed-dose combination (FDC) of relugolix (40 mg), estradiol (1 mg), and norethindrone acetate (0.5 mg) was developed to address these limitations. This open-label, randomized, two-treatment, two-sequence, four-period, crossover bioequivalence study was conducted in 48 healthy postmenopausal women under fasting conditions. Participants received a single oral dose of either the RELUEASE (Sun Pharmaceutical Industries Limited, India) or the reference product (MYFEMBREE) (Patheon Inc., Mississauga, Ontario), with a 21-day washout. Pharmacokinetics parameters were derived using non-compartmental analysis. Bioequivalence assessment was performed using a linear mixed-effects model applied to ln-transformed pharmacokinetic parameters. A total of 39 participants completed all study periods. The point estimates and 90% confidence intervals (CIs), or the 95% upper bound for the pharmacokinetic parameters (C
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