hormone concentration-time curve, and MVT-602 PK parameters were determined. RESULTS: The median (minimum, maximum) change from baseline for peak serum LH response were 3.5 (1.1, 25.5), 10.0 (2.9, 75.4), and 8.1 (3.1, 11.9) IU/L for the three escalating MVT-602 doses (0.3, 1, or 3 mg, respectively) with little change observed in the placebo group, 3.6 (0.0, 6.1) IU/L. The peak LH response generally occurred 24 hours postdose and returned to baseline approximately 72 hours postdose. An area-under the serum LH curve also showed a plateauing, albeit less variable, doseresponse relationship. The day of dosing relative to menstrual start and baseline LH concentration appeared to positively correlate with response. Increases in serum E2 appeared to correlate with LH response. Little dosedependent changes in FSH or P were observed. The peak plasma MVT-602 concentration was observed $30 minutes post-dose, suggesting rapid absorption from the injection site; the plasma half-life was <3 hours. MVT-602 was well tolerated; no serious adverse events (AEs) or severe AEs were reported. The most frequent treatment-emergent AE was headache (placebo n¼3; 0.3 mg n¼3; 1 mg n¼3; 3 mg n¼4). No dose response was observed for any AE. CONCLUSIONS: MVT-602 stimulated the release of LH and was welltolerated when administered to healthy premenopausal women in the follicular phase. The dose-dependent changes in serum LH suggest MVT-602 is a promising agent to stimulate the hypothalamic-gonadotropin axis and trigger oocyte maturation and ovulation. Supported by: Sponsored by Myovant Sciences GmbH.
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