"Oct. 20, 2012 -- Babies conceived with the help of high-tech fertility treatments such as in vitro fertilization (IVF) have an increased risk for birth defects, a new study shows.
Compared to infants born to mothers who conceived with"...
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Menopur® (menotropins injection) , administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. In order to produce final follicular maturation and ovulation in the absence of an endogenous LH surge, hCG must be administered following Menopur® (menotropins injection) treatment, at a time when patient monitoring indicates sufficient follicular development has occurred.
Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of Menopur® (menotropins injection) . Study 2003-02 compared single doses of SC administration of the US and European (EU) formulations of Menopur® (menotropins injection) 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® (menotropins injection) administered SC and IM 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 Cmax values. The results are summarized in Table 1.
Table 1: Mean (±SD) FSH Pharmacokinetic Parameters
Following Menopur® (menotropins injection) Administration (Study 2000-03)
|PK Parameters|| Single Dose
| Multiple Dose
(225 IU x 1 day then 150 IU x 6 days)
|Cmax† (mlU/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-mIU/mL)||726.2 (243.0)||656.1 (233.7)||622.7 (153.0)||546.2 (91.2)|
|†Single dose Cmax,AUC120 and multiple dose Cmaxss, AUCss|
The SC route of administration trends toward greater bioavailability than the IM route for single and multiple doses of Menopur® (menotropins injection) .
Human tissue or organ distribution of FSH and LH has not been studied for Menopur® (menotropins injection) .
Metabolism of FSH and LH has not been studied for Menopur® (menotropins injection) in humans.
The elimination half-lives for FSH in the multiple-dose phase were similar (11-13 hours) for Menopur® (menotropins injection) SC and Menopur® (menotropins injection) IM.
Menopur® (menotropins injection) has not been studied in the pediatric population.
Menopur® (menotropins injection) has not been studied in the geriatric population.
The safety and efficacy of Menopur® (menotropins injection) in renal and hepatic insufficiency have not been studied.
No drug/drug interaction studies have been conducted for Menopur® (menotropins injection) in humans.
The efficacy and safety of Menopur® (menotropins injection) have been established in one randomized, controlled, clinical study, 0399E, of women undergoing in vitro fertilization (IVF) or IVF plus intracytoplasmic injection to achieve pregnancy.
Study 0399E was a Phase 3, randomized, open-label, multicenter, multinational (in Europe and Israel), comparative clinical trial of ovulatory, infertile females undergoing ovarian stimulation to produce multiple follicles for IVF and embryo transfer (IVF/ET) after pituitary suppression with a GnRH agonist. A total of 373 patients were randomized to the Menopur® (menotropins injection) arm. Randomization was stratified by insemination technique [conventional in-vitro fertilization (IVF) vs. intra-cytoplasmic sperm injection (ICSI)]. Efficacy was assessed based on the primary efficacy parameter of continuing pregnancy. The initial daily dose of Menopur® (menotropins injection) was 225 IU SC for five days. Thereafter, the dose was individualized according to each patient's response, up to a maximum of 450 lU/day for a total maximum duration of stimulation of 20 days. Treatment outcomes are summarized in Table 2.
Table 2: Efficacy Outcomes for IVF Study 0399E (one cycle
|Continuing Pregnancy (%)a||87 (23) b|
|Clinical Pregnancy (%)||98 (26)c|
|aContinuning pregnancy was defined as ultrasound
visualization of a gestational sac with fetal heartbeat at > 10 weeks
bNon-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis
cSecondary efficacy parameter. Study 0399E was not powered to demonstrate differences in this parameter
Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.
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