Luveris (Lutropin Alfa Subcutaneous) - Drug Info, Side Effects, Research, Clinical Trials

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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:

Patients should have baseline serum hormone levels of LH < 1.2 IU/L and FSH < 5 IU/L.
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.
Patients should have a negative progestin challenge test.
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.
Evaluation of the partner’s fertility potential should be included in the initial evaluation.

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NEWS HIGHLIGHTS

Media Articles Related to Luveris (Lutropin Alfa Subcutaneous)

Premature Hardening Of The Zona Pellucida Can Be A Cause Of Infertility
Source: Fertility News From Medical News Today [2013.04.26]
Scientists in Mainz and Aachen have discovered a new mechanism that controls egg cell fertility and that might have future therapeutic potential. It was revealed by Professor Dr. Walter Stocker of the Institute of Zoology at Johannes Gutenberg University Mainz (JGU) that the blood protein fetuin-B plays an important and previously unknown role in the fertilization of oocytes...

Infertility: Ten Infertility Questions to Ask Your Doctor
Source: MedicineNet Uterine Growths Specialty [2012.05.21]
Title: Infertility: Ten Infertility Questions to Ask Your Doctor
Category: Doctor's Views
Created: 6/21/2005 12:00:00 AM
Last Editorial Review: 5/21/2012 12:00:00 AM

Infertility Pictures Slideshow: Which Treatment Is Right for You?
Source: MedicineNet Turner Syndrome Specialty [2011.10.20]
Title: Infertility Pictures Slideshow: Which Treatment Is Right for You?
Category: Slideshows
Created: 12/10/2010 5:53:00 PM
Last Editorial Review: 10/20/2011 12:00:00 AM

Infertility
Source: MedicineNet Turner Syndrome Specialty [2009.07.29]
Title: Infertility
Category: Diseases and Conditions
Created: 11/17/2004 12:00:00 AM
Last Editorial Review: 7/29/2009 12:00:00 AM

Potential For Novel Treatments Of Uterine Fibroids
Source: Fertility News From Medical News Today [2013.06.11]
Uterine leiomyomata, or fibroids, are benign tumours that nevertheless affect the health of millions of women. They may cause, for instance, pain, bleeding and infertility. Fibroids are also the most common reason for a hysterectomy; for example, some 8,000 hysterectomies are made in Finland each year...

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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)

A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age [Recruiting]
Ovarian reserve is related to chronological age and age 35 years is the accepted threshold for significant decline in assisted reproductive technologies (ART) success with scarce follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to improve follicular response in ovarian ageing because of the increasing number of infertile women aged > 35 years who are seeking pregnancy. The advent of gonadotropin releasing hormone analogue antagonist (GnRHant) offers new perspectives to address the advanced reproductive age since it allows for preventing premature luteinizing hormone (LH) surges while not causing suppression in the early follicular phase. Gonadotropin releasing hormone analogue antagonist are administered in the latter stage of the ovarian stimulation to prevent LH surge by competitive blockade of GnRH receptors, thus producing a marked decrease in LH levels just when the interplay between follicle stimulating hormone (FSH) and LH is important to complete follicular development and oocyte competence. Some studies in the past have shown the potential of recombinant human LH (r-hLH) supplementation in older reproductive age to improve oocyte quality, but these studies are of small size and did not provide data on the physiological mechanism behind the benefit obtained.

This randomised, comparative with parallel control, phase II study will be conducted in infertile female subjects aged 35-42 years undergoing in-vitro fertilisation/intra cytoplasmic sperm injection (IVF/ICSI), to investigate whether the addition of r-hLH (when the lead follicle is > 14 mm in size), to the standard protocol with recombinant human FSH (r-hFSH) under GnRHant, improves the number and quality of oocytes retrieved, implantation rate, and pregnancy rate, while assessing the hormonal milieu in ovarian follicular fluid. Comparison will be performed against ovarian stimulation without addition of r-hLH, i. e. with r-hFSH under GnRHant alone.

A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-fï¿½ and Luverisï¿½ Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique [Recruiting]
This is a phase IIIb, interventional, multicentre, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on day 1 or day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).

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. LuverisÂ® (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.

Luverisï¿½(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

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