The aim of the current study was the pharmacokinetic and pharmacodynamic characterization of a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products.
Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
19
Glycotope Investigational Site
Groningen, Netherlands
to assess the safety and (local) tolerability of FSH-GEX™ following single rising dose administration by subcutaneous injection
frequency of dose related adverse events, measurement of vital signs, body measurements, transvaginal ultrasound, ECG and laboratory values in comparison to placebo and the two comparators with marketing authorization
Time frame: up to 87 days
to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 1)
Peak plasma concentration (Cmax)
Time frame: before FSH/Placebo administration until 240 hours thereafter
to determine FSH pharmacokinetic parameters of FSH-GEX™ following single dose administration by subcutaneous injection (part 2)
Area under the plasma concentration versus time curve (AUC)
Time frame: before FSH/Placebo administration until 240 hours thereafter
to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 1)
determined by Estradiol (E2) and inhibin B concentrations depending on dose
Time frame: before FSH/Placebo administration until 240 hours thereafter
to assess the pharmacodynamic effect of FSH-GEX™ following single rising dose administration by subcutaneous injection (part 2)
ovarian follicle number and size as determined by transvaginal ultrasonography depending on dose
Time frame: up to a maximum of 87 days
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single dose