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Cotonnec, J. Y. Le; Porchet, HervéClaude; Beltrami, Vanya; Khan, Abdul Haleem; Toon, S.; Rowland, Malcolm

doi:10.1023/a:1016204919251

Cited by 10 publications

(2 citation statements)

References 13 publications

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“…The pharmacokinetic properties of follitropin are similar to those of follitropin . The terminal half-life is approximately 1 day, so monitoring for at least 3-4 days beyond administration of the last dose is necessary to evaluate the efficacy of treatment [37]. The follitropin has a terminal half-life of 30-40 hours [38].…”

Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Present and Future of Recombinant Gonadotropins in Reproductive Medicine

Leo¹,

Musacchio²,

Sabatino³

et al. 2012

CPB

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Pharmacological ovarian stimulation has a major role in reproductive medicine and has been used in anovulatory patients and in the induction of multifollicular development required for the procedures of assisted reproductive techniques (ART). Currently, gonadotropins are the most important tools to proceed with ovarian stimulation for all purposes, including ART and anovulation disorders, like hypogonadotropic hypogonadism and hypothalamic hypophyseal dysfunction. Gonadotropin preparations derived from human urine have been used clinically since the early 1960s and the first urine-derived preparation containing only FSH (urofollitropin) became available in 1983. More recently, the application of recombinant DNA technology has resulted in the development of recombinant FSH produced in mammalian cells. In the last period, LH became available by recombinant DNA technology and is now a new option for protocols of ovarian stimulation. Treatment with gonadotropins has been shown to be effective in males affected by hypogonadotropic hypogonadism. This success has resulted in attempts to utilize FSH therapy in oligozoospermic men, aimed at obtaining a quantitative increase in sperm count. The purpose of this review was to examine the pharmacological aspects and different clinical applications of recombinant gonadotropins (FSH, LH, hCG) in the treatment of female infertility in all its aspects and their use also in the treatment of male infertility. This review will trace these events, from the past through to the present, and conclude with a glance towards the future.

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Section: Pharmacokinetics and Pharmacodynamicsmentioning

confidence: 99%

Present and Future of Recombinant Gonadotropins in Reproductive Medicine

Leo¹,

Musacchio²,

Sabatino³

et al. 2012

CPB

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“…In pituitary-suppressed healthy women, serum FSH concentrations reach a maximum after 22 – 27 hours, and the terminal half-life is 39 – 45 hours after a single subcutaneous dose [ 5 ]. The bioavailability is similar after subcutaneous and intramuscular administration [ 6 ] and was determined to be 74% after intramuscular administration [ 7 ]. Regardless of their purity, the pharmacokinetic (PK) profile of menotropins is dose-proportional [ 5 , 8 ].…”

Section: Introductionmentioning

confidence: 99%

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

Jonker

Koch²,

Larsson

et al. 2021

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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.

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