Endogen HP Mechanism of Action

Pharmacology: Pharmacodynamics: Urofollitropin (Endogen HP) administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Urofollitropin (Endogen HP) in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG 7500 IU must be given to induce ovulation.
Pharmacokinetics: Published clinical data reveals that there is a variation in AUC and Cmax depending on the route of administration. Pharmacokinetic data obtained by SC & IM routes are not bioequivalent.
Absorption: The maximum plasma concentration of FSH was attained at 20.5 and 17 .4 hours following SC and IM single dose administration, respectively. However, following multiple dosing, it was attained at approximately 10 hours following both routes of administration.
Distribution: Human tissue or organ distribution of FSH has not been studied.
Metabolism: Metabolism of FSH has not been studied in humans.
Elimination: Published clinical studies have demonstrated the mean elimination half-lives of FSH for SC and IM single dosing are 31.8 and 37 hours, respectively. However, following multiple dosing (x7 days) they are 20.6 and 15.2 hours for SC and IM, respectively.
Pediatric Populations: Urofollitropin (Endogen HP) is not indicated in pediatric populations.
Geriatric Populations: Urofollitropin (Endogen HP) is not indicated in geriatric populations.
Special Populations: The safety and efficacy of Urofollitropin (Endogen HP) in renal and hepatic insufficiency have not been studied.