Clinical trials on long-awaited 'Male Pill'
Schering launches clinical trials on long-awaited 'Male Pill'
Auckland, January 27, 2004 The development of a contraceptive pill for men has moved a step closer with Schering AG of Germany and dutch company Organon announcing the start of a major clinical trial, designed to test the reliability and safety of the so-called 'Male Pill'.
Schering New Zealand says the European trial is expected to be completed by December 2005. The drug could be available in this country within 5-7 years.
The international study, which will be conducted in 14 centers throughout Europe, is one of the largest trials of a hormonal fertility control method for men.
"Research in fertility control has traditionally concentrated on methods for women and with the 'male pill' we aim to increase the choice of methods available to couples," said Professor Gunter Stock, member of the Executive Board of Schering AG responsible for Research.
"Schering and Organon have decided to join forces in the development of a male fertility control method. With our joint study we make a big step forward in the development of the first hormonal fertility control for men which has the potential to be marketed worldwide."
The study will involve 350 men in 14 centers throughout Europe. Following encouraging results from earlier pilot studies, the present challenge for both companies is to develop a method that is not only reliable, safe and reversible but also acceptable to users.
The trial medication and modes of administration are based on results from earlier studies showing that sperm concentrations can be suppressed to contraceptive levels by the progestogen etonogestrel.
In the trial, the progestogen, developed by Organon, is given in implant form. As this hormone inhibits the body's testosterone production, the test persons are injected with a long-acting testosterone undecanoate developed by Schering, which maintains testosterone levels in the blood within the normal range.
This phase II study will evaluate six dose combinations of etonogestrel and testosterone undecanoate.
Schering New Zealand is the largest contraceptive provider in New Zealand with products ranging from Microgynon 30 (a combined oral contraceptive pill) to Levonelle; an over the counter emergency contraceptive pill to the unique Mirena a hormonal intrauterine device.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Diagnostics&Radiopharmaceuticals, Dermatology as well as Specialized Therapeutics for disabling diseases in the fields of the central nervous system, oncology and cardiovascular system. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work
This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
Find additional information at: www.schering.de
MIRENA. Prescription Medicine. The MIRENA system contains 52mg levonorgestrel with an initial release rate of 20mg/24 hours. For contraception or menorrhagia without pathology. MIRENA must not be used during pregnancy or if there is any sign of pelvic or genital tract infection or inflammation, uterine or cervical malignancy or anomaly or undiagnosed abn="Geneva, Arial, Sans-serif"> or Schering NZ Ltd, P.O. Box 101 691 NSMC Auckland.
Levonelle is a Prescription
Medicine except when it is sold by an accredited pharmacist
or nurse. LEVONELLE contains two tablets of 750 micrograms
of levonorgestrel and is an emergency contraceptive for
women. It must be taken strictly as directed following the
enclosed pack instructions. LEVONELLE must not be taken if
pregnancy is suspected or confirmed. See your doctor
weeks after taking LEVONELLE. Possible side effects are nausea, irregular menstrual bleeding, breast tenderness and abdominal pain
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and object