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Mechanism Of Action
MENOPUR®, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with MENOPUR® in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.
Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of MENOPUR®. Study 2003-02 compared single doses of subcutaneous administration of the US and European (EU) formulations of MENOPUR® in 57 healthy, pre-menopausal females who had undergone pituitary suppression. The study established that the two formulations are bioequivalent. Study 2000-03 assessed single and multiple doses of MENOPUR® administered subcutaneously and intramuscularly in a 3 phase cross-over design in 33 healthy, pre-menopausal females who had undergone pituitary suppression. The primary pharmacokinetic endpoints were FSH AUC and C max values. The results are summarized in Table 2.
Table 2: FSH Pharmacokinetic Parameters [Mean (SD)]
Following MENOPUR® Administration (Study 2000-03)
|PK Parameters||Single Dose (225 IU)||Multiple Dose (225 IU x 1 day then 150 IU x 6 days)|
|Cmax* (mIU/mL)||8.5 (2.5)||7.8 (2.4)||15.0 (3.6)||12.5 (2.3)|
|Tmax (hr)||17.9 (5.8)||27.5 (25.4)||8.0 (3.0)||9.0 (7.0)|
|AUC† (hr-mlU/mL)||726.2 (243.0)||656.1 (233.7)||622.7 (153.0)||546.2 (91.2)|
|* Single dose Cmax , AUC 120 and multiple dose Cmaxss , AUC ss|
The subcutaneous route of administration trends toward greater bioavailability than the intramuscular route for single and multiple doses of MENOPUR® .
Human tissue or organ distribution of FSH and LH has not been studied for MENOPUR® .
Metabolism of FSH and LH has not been studied for MENOPUR® in humans.
The elimination half-lives for FSH in the multiple-dose phase were similar (11-13 hours) for subcutaneously administered MENOPUR® and intramuscularly administered MENOPUR® .
The efficacy of MENOPUR® was established in one randomized, open-label, multicenter, multinational (in Europe and Israel), comparative clinical trial of women undergoing in vitro fertilization (IVF) or IVF plus intracytoplasmic injection (ICSI) to achieve pregnancy.
All women began ovarian stimulation as part of an IVF cycle following pituitary suppression with a GnRH agonist. A total of 373 patients were randomized to the MENOPUR® arm. Randomization was stratified by insemination technique [conventional IVF vs. ICSI]. Efficacy was assessed based on the primary efficacy parameter of continuing pregnancy. The initial daily dose of MENOPUR ® was 225 International Units administered subcutaneously for five days. Thereafter, the dose was individualized according to each patient's response, up to a maximum of 450 IU/day for a total maximum duration of stimulation of 20 days. Treatment outcomes are summarized in Table 3.
Table 3: Efficacy Outcome in IVF Study (one cycle of
|Parameter||Subcutaneously Administered MENOPUR®
|Continuing Pregnancy (%)a||87 (23)b|
|Clinical Pregnancy (%)||98 (26)c|
|aContinuing pregnancy was defined as ultrasound
visualization of gestational sac with fetal heartbeat at ≥ 10 weeks after ET
b Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis c Secondary efficacy parameter. Study was not powered to demonstrate differences in this parameter
Last reviewed on RxList: 2/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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