Menotropins administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with menotropins in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

PHARMACOKINETICS

Single doses of 300 IU menotropins (Menogon®, Ferring's European formulation) were administered subcutaneously (SC) and intramuscularly (IM) in a 2-period crossover study to 16 healthy female subjects while their endogenous FSH and LH were being suppressed. Serum FSH concentrations were determined. Based on the ratio of FSH C_max and AUC_0-¥, SC and IM administration of menotropins are not bioequivalent. Compared to IM administration, the SC administration of menotropins results in an increase of FSH C_max and AUC_0-¥ by 35 and 20%, respectively.

Based on two subjects who received either the highest SC or IM Repronex dose, FSH pharmacokinetics (PK) appears to be linear up to 450 IU menotropins. The mean accumulation factors for FSH upon six doses of SC or IM 150 to 450 IU/day Repronex are 1.6 and 1.4, respectively. Upon six doses of SC or IM 150 IU/day Repronex, the observed serum FSH concentrations range from 1.7 to 15.9 mIU/mL and 0.5 to 10.1 mIU/mL, respectively. The FSH pharmacokinetic parameters from population modeling for these two studies are in Table 1.

† mean (CV%)
‡ Menogon® (Ferrings European formulation of menotropins)
¶ Repronex®

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