Luveris (Lutropin Alfa Subcutaneous) - Summary

LUVERIS SUMMARY

Luveris ^®
(LUTROPIN ALFA FOR INJECTION)
FOR SUBCUTANEOUS USE

Luveris^® (lutropin alfa for injection) is a sterile lyophilized powder composed of recombinant human luteinizing hormone, r-hLH. Therapeutic Class: Infertility.

Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH < 1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. The safety and effectiveness of concomitant administration of Luveris^® with any other preparation of recombinant human FSH or urinary human FSH is unknown.

Selection of Patients:

1. Patients should have baseline serum hormone levels of LH < 1.2 IU/L and FSH < 5 IU/L.

2. Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy and exclusion of pregnancy.

3. Patients should have a negative progestin challenge test.

4. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Luveris^® and follitropin alfa therapy.

5. Evaluation of the partner’s fertility potential should be included in the initial evaluation.

NEWS HIGHLIGHTS

Media Articles Related to Luveris (Lutropin Alfa Subcutaneous)

Infertility treatments may raise preterm birth risk (Reuters)
Source: Y! Health Pregnancy News [2010.03.18]
Reuters - Couples who conceive through certain types of infertility treatment may have a higher-than-normal likelihood of having a premature baby, a new study suggests.

Home SpermCheck Test Helps Couples Hoping To Conceive Better Understand Infertility Issues
Source: Fertility News From Medical News Today [2010.03.12]
Infertility affects between 10 and 15 percent of couples worldwide. Surprisingly, problems with male fertility account for approximately 50 percent of infertility cases. A new home test kit based on a protein in sperm discovered by University of Virginia Health System cell biologist John C. Herr, PhD, can assist couples in determining if a man's sperm count is normal, low, or very low...

Leading U.S. Infertility Practice Opens Boston IVF The Maine Center In Portland, Helping Build Families In Maine
Source: Fertility News From Medical News Today [2010.02.25]
Boston IVF, a leading medical practice providing specialized infertility treatment since 1986, is expanding its patient care services in Maine and has opened Boston IVF The Maine Center, offering local patients state-of-the-art care closer to home...

Infertility
Source: MedicineNet Endometrial Biopsy Specialty [2007.02.07]
Title: Infertility
Category: Diseases and Conditions
Created: 11/17/2004
Last Editorial Review: 2/7/2007

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Published Studies Related to Luveris (Lutropin Alfa Subcutaneous)

Recombinant LH (lutropin alfa) for the treatment of hypogonadotrophic women with profound LH deficiency: a randomized, double-blind, placebo-controlled, proof-of-efficacy study. [2008.09]
OBJECTIVE: To confirm the safety and efficacy of 75 IU lutropin alfa with concomitant follitropin alfa in inducing follicular development in women with profound gonadotrophin deficiency... CONCLUSION: Subcutaneous co-administration of 75 IU lutropin alfa with follitropin alfa is safe and effective in inducing follicular development in women with profound gonadotrophin deficiency.

Recombinant LH (lutropin alfa) for the treatment of hypogonadotrophic women with profound LH deficiency: a randomized, double-blind, placebo-controlled, proof-of-efficacy study. [2008.05.14]
Objective To confirm the safety and efficacy of 75 IU lutropin alfa with concomitant follitropin alfa in inducing follicular development in women with profound gonadotrophin deficiency.Conclusion Subcutaneous co-administration of 75 IU lutropin alfa with follitropin alfa is safe and effective in inducing follicular development in women with profound gonadotrophin deficiency.

Bupropion: a review of its use in the management of major depressive disorder. [2008]
Bupropion is presumed to be a dopamine-norepinephrine reuptake inhibitor and is an effective antidepressant. It is available as three oral formulations: (i) bupropion immediate release (IR) [Wellbutrin] administered three times daily; (ii) bupropion sustained release (SR) [Wellbutrin SR] administered twice daily; and (iii) bupropion extended/modified release (XR) [Wellbutrin XL/Wellbutrin XR] administered once daily...

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Clinical Trials Related to Luveris (Lutropin Alfa Subcutaneous)

The Luveris In Vitro Fertilization Trial [Recruiting]
The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).

We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels.

The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.

Luveris®(Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (LH <1.2 IU/L) [Recruiting]
To confirm the efficacy of the 75 IU dose of Luveris® compared to placebo when administered concomitantly with follitropin alfa for induction of clinical pregnancy in women with hypogonadotropic hypogonadism and profound LH deficiency (LH <1. 2 IU/L), and to study the efficacy of a lower dose (25 IU) of Luveris® compared to placebo when administered concomitantly with follitropin alfa for induction of follicular development in women with hypogonadotropic hypogonadism and profound LH deficiency (LH <1. 2 IU/L).

Study to Evaluate r-hLH (Luveris®) in Infertile Women Undergoing Assisted Reproductive Technology (ART) [Recruiting]
The primary objective of this study is to determine whether the addition of Luveris® to follicle stimulating hormone (FSH) at day 8 of ovarian stimulation can reduce the dose and/or duration of FSH.

The secondary objectives of the study are to determine:

- whether the addition of Luveris® to FSH at day 8 of ovarian stimulation improves cycle

outcome

- safety

Efficacy and Safety of R-hLH (Luveris ®) Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET [Completed]
In programmes of IVF, normal women undergo controlled ovarian stimulation using exogenous FSH injections to obtain multiple eggs. The process results in eggs of mixed quality with a broad range of developmental and implantation potential.

The aim of the study was to determine whether, treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF. High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos. The mature oocyte is the most important determinant of embryo quality. Early follicles, containing immature eggs, have LH receptors in the theca cells that surround the follicle, and LH stimulates these cells to produce factors essential for normal follicular development.

The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles, so that they can all mature together, thus increasing the proportion of high grade oocytes and their subsequent embryos

Synchronization of Follicle Wave Emergence and Ovarian Stimulation [Recruiting]
The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.

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