Navigation Links
Two Phase III clinical trials on corifollitropin alfa (Org 36286),reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the human healthcare business unit of Akzo Nobel, announced today that two out of three Phase III clinical trials with corifollitropin alfa (Org 36286), a new long-acting fertility hormone, have reached their randomization target.

Corifollitropin alfa is a new recombinant fertility hormone. It is the first of a new class of gonadotropins (a sustained follicular stimulant or SFS) of which, due to its long half-life, one single injection may replace the first 7 injections with conventional gonadotropins during a fertility treatment cycle.

The objective of the ENGAGE trial, the largest double-blind fertility trial ever performed, is to demonstrate clinical efficacy and safety of corifollitropin alfa 150 µg in a double-blind comparison with Organon’s Puregon®, one of the most commonly used preparations to treat infertile patients. The recruitment goal of the ENGAGE trial was to include a total of 1400 patients from 34 fertility clinics in Europe, USA and Canada and was started in July, 2006. The study reached its randomization target on June 10, 2007.

A second trial, the ENSURE trial, is an efficacy and safety trial with corifollitropin alfa 100 µg designed specifically for women who weigh less than 60 kg (133 lbs). This double-blind study comparing corifollitropin alfa with Puregon® was started in January 2007 in 19 clinical trial centers in Europe and Asia with a recruitment goal of 330 patients by June 30, 2007. All 330 subjects have now been randomized.

David Nicholson, executive vice-president Research and Development at Organon commented: “The enthusiasm and dedication of investigators and staff involved in these trials was decisive in reaching our recruitment targets.”

A third Phase III trial in the LIFE program (the TRUST trial) focuses on safety of repeated treatments with corifollit ropin alfa, and is expected to complete recruitment on target by mid-August 2007.

About corifollitropin alfa
• Corifollitropin alfa is a new biological entity (NBE) and is being developed for controlled ovarian stimulation to induce the development of multiple follicles in patients participating in an assisted reproductive technology program.
• Corifollitropin alfa is the first compound in a new class of long-acting fertility hormones called ‘Sustained Follicle Stimulants’ (SFS). The primary advantage of an SFS over current gonadotropins is the longer duration of action which allows a treatment regimen replacing 7 daily injections of current gonadotropins with one injection of corifollitropin alfa.
• The LIFE program is Organon’s clinical development program for corifollitropin alfa for the therapeutic indication of controlled ovarian stimulation. The most important trials in this program are studies with the names ENGAGE (phase III efficacy and safety study with corifollitropin alfa 150 mcg), ENSURE (phase III efficacy and safety study in women =60 kg with corifollitropin alfa 100 mcg) and TRUST (phase III safety study on repeated treatment).

For media inquiries
Elina Daamen

N.V. Organon (Media Relations)
Visiting address: Molenstraat 110
5342 CC Oss
The Netherlands
Mailing address:

Elina Daamen, media relations

NV Organon

Tel: +31-412-663685

Fax: +31 (0) 412 662568
Email address:

About Organon
Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
3. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
7. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
8. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
9. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
10. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
11. Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery
Post Your Comments:
(Date:11/29/2015)... 29, 2015   Royal Philips  (NYSE: PHG, AEX: ... at the 2015 Radiological Society of North America Annual ... Place in Chicago . Visitors to ... company,s broad portfolio of integrated Diagnostic Imaging, Clinical Informatics, ... clinical performance, improve workflow and create a superior patient ...
(Date:11/29/2015)... Nov. 29, 2015   National Decision Support Company ... client base, including notable statewide implementations. As a ... solution, ACR Select, more than 1 million times ... workflow. ACR Select provides real-time feedback on the ... and has been implemented at over 100 healthcare ...
(Date:11/27/2015)... PHILADELPHIA , Nov. 27, 2015  Lannett ... that it has completed the acquisition of Kremers ... pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A. ... --> Lannett has acquired KU from UCB ... to certain adjustments, including a customary working capital ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Sikka Software announced today ... Meeting. Their Ecosystem empowers dentists to make complex business decisions by providing the tools ... receive a free fee survey with 10 procedures customized by zip code. , ...
(Date:11/30/2015)... ... 30, 2015 , ... Scott Newman MD, FACS of New ... plastic surgeons in the New York City area to utilize the new, non-invasive ... heat-induced laser treatment for fat loss in the abdomen, flanks, and other areas ...
(Date:11/30/2015)... Atlanta, Georgia (PRWEB) , ... November 30, 2015 ... ... training for healthcare professionals worldwide today released the results of a survey of ... Middle East and Africa found a growing global demand for high quality online ...
(Date:11/30/2015)... Miami, FL (PRWEB) , ... November 30, 2015 ... ... manufacturer and engineer of patented products, announces the Unstoppable Swappables, a household invention ... Window Coverings Industry makes $2 billion a year and is growing at 2.6%," ...
(Date:11/29/2015)... Michigan (PRWEB) , ... November 29, 2015 , ... "I ... games. Things that as a Mother and Wife would love to do, I missed. ... that I just happened to call Dr. Zaidan first. They have changed my life ...
Breaking Medicine News(10 mins):