First pre-filled pen device with highly purified human menopausal gonadotropin (HP-hMG, Menopur) in liquid is shown to be bioequivalent to powder for reconstitution

Abstract

Objective: To determine whether serum human follicle-stimulating hormone (FSH) levels after single subcutaneous dosing of highly purified human menopausal gonadotropins (HP-hMG) in a liquid formulation and a powder formulation are bioequivalent. Materials and methods: This was a randomized, 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 AUC t and C max of baseline-adjusted FSH. Pituitary-suppressed, healthy women were administered single subcutaneous injections of 450 IU Menopur liquid (600 IU/0.96 mL) and 450 IU Menopur powder (by 2 subcutaneous injections of 225 IU in 1 mL) in a randomized order. The pharmacokinetic parameters of FSH and human chorionic gonadotropin (hCG) were assessed by non-compartmental methods with adjustment for endogenous pre-dose levels. Results: In total, 76 women were randomized, and 56 completed the trial. The mean FSH and hCG serum concentration-time profiles were comparable between the two HP-hMG formulations. The geometric mean ratios and 90% confidence intervals of FSH for HP-hMG liquid versus HP-hMG powder were 1.12 (1.0562 – 1.1889) for AUC t and 1.17 (1.0946 – 1.2490) for C max , showing that the two formulations were bioequivalent. The incidence and severity of adverse events were similar between the two preparations, and both preparations were well tolerated. Conclusion: The 90% CIs for the geometric mean ratios of serum FSH AUC t and C max were both within 0.8000 – 1.2500, thus the two formulations are bioequivalent.

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR®)

“…The pen has a 31G needle (8 mm long with 6-bevel geometry) and is capable of delivering doses from 6.25 to 450 IU HP-hMG in increments of 6.25 IU. 22 A prototype unbranded pen containing a placebo cartridge ( Figure 1B ) was provided to study respondents together with a demo cushion to enable a practice injection to be performed under supervision from the remote interview moderator. Respondents were required to attach the needle to the prototype pen and prime the device before performing the practice injection.…”