P –587 Highly purified human menopausal gonadotrophin (HP-hMG, Menopur) as a ready-to-use solution for injection in pre-filled pen is bioequivalent to HP-hMG powder for reconstitution

AbstractStudy questionAre serum FSH levels after single subcutaneous dosing of HP-hMG in a liquid formulation and a powder formulation bioequivalent?Summary answerThe 90% CIs for the geometric mean ratios of serum FSH AUCt and Cmax were both within 0.8000 –1.2500, thus the two formulations are bioequivalent.What is known alreadyFor several decades, HP-hMG (Menopur) has been used for the treatment of infertility; its efficacy and safety compared to other gonadotropins have been consistently demonstrated in several prospective, randomised controlled trials and meta-analyses (Deeks et al 2018; Bordewijk et al 2019). Menopur powder for reconstitution is available in multidose and single dose formulations. Up to 3 single dose vials (each containing 75  IU) may be dissolved into 1 mL solvent for administration. Recently, and for the first time, Menopur has been successfully formulated in a stable, ready-to-use solution for injection, which may be administered by a pre-filled pen.Study design, size, durationThis was a randomised, two-way crossover, single dose, bioequivalence trial comparing Menopur liquid injected by pre-filled pen, with Menopur powder injected by conventional syringe and needle. The primary endpoints were AUCt and Cmax of baseline-adjusted FSH. Pituitary-suppressed, healthy women were randomised to receive one treatment sequence including a single subcutaneous injection of 450  IU Menopur liquid (600 IU/0.96 mL) and of 450 IU Menopur powder by two su...
Source: Human Reproduction - Category: Reproduction Medicine Source Type: research