男性避孕药植入术可能即将开始
LONDON, Jul 11 (Reuters Health) - Major clinical studies to test a male contraceptive implant have started in Europe and the US, Dutch pharmaceutical company Organon announced on Wednesday.
If all goes well in these and other trials, a hormonal contraceptive for men could reach the market some time after 2005, the firm's UK medical director Henk Jan Out said.
He denied that the firm had chosen to investigate implants because, unlike pills, men cannot forget to take them. He pointed out that studies using pills were also under way but the firm wanted to study implants because they release a constant dose of hormone, whereas pills are subject to peaks and troughs.
In a statement, the firm said 120 male volunteers, between the ages of 18 and 45, in three European centres and the US would receive implants containing etonogestrel. The hormone--released from tiny rods implanted under the skin of the arm--blocks sperm production. The men will have testosterone injections every 4 to 6 weeks to maintain their other male characteristics.
"The results of the study are expected by the end of 2002, and will provide the answer to whether long-term reliable, safe and reversible hormonal contraception for men can be achieved by the method being tested," the firm said.
Organon announced last year it was starting full-scale clinical trials of a potential male contraceptive following "very encouraging" results by researchers at the Centre for Reproductive Biology in Edinburgh.
The Scottish study in which 60 men received the female hormone progestogen desogestrel and a testosterone implant showed a zero sperm count in all cases. Researchers noted that the side effects were similar to those sometimes seen with women taking oral contraceptives.
"The results found in studies performed until now have been so encouraging, showing completely reversible blockade of sperm production without major side effects, that we can't wait to move forward and start with this new study," said Dr. Fred Wu from Manchester Royal Infirmary, one of the participating centres.
Dr. Richard Anderson, study investigator at the Centre for Reproductive Biology said, "This will finally prove whether a male 'pill' is a figment of our scientific imagination or whether it will become a reality within the next 5 to 6 years.", 百拇医药
If all goes well in these and other trials, a hormonal contraceptive for men could reach the market some time after 2005, the firm's UK medical director Henk Jan Out said.
He denied that the firm had chosen to investigate implants because, unlike pills, men cannot forget to take them. He pointed out that studies using pills were also under way but the firm wanted to study implants because they release a constant dose of hormone, whereas pills are subject to peaks and troughs.
In a statement, the firm said 120 male volunteers, between the ages of 18 and 45, in three European centres and the US would receive implants containing etonogestrel. The hormone--released from tiny rods implanted under the skin of the arm--blocks sperm production. The men will have testosterone injections every 4 to 6 weeks to maintain their other male characteristics.
"The results of the study are expected by the end of 2002, and will provide the answer to whether long-term reliable, safe and reversible hormonal contraception for men can be achieved by the method being tested," the firm said.
Organon announced last year it was starting full-scale clinical trials of a potential male contraceptive following "very encouraging" results by researchers at the Centre for Reproductive Biology in Edinburgh.
The Scottish study in which 60 men received the female hormone progestogen desogestrel and a testosterone implant showed a zero sperm count in all cases. Researchers noted that the side effects were similar to those sometimes seen with women taking oral contraceptives.
"The results found in studies performed until now have been so encouraging, showing completely reversible blockade of sperm production without major side effects, that we can't wait to move forward and start with this new study," said Dr. Fred Wu from Manchester Royal Infirmary, one of the participating centres.
Dr. Richard Anderson, study investigator at the Centre for Reproductive Biology said, "This will finally prove whether a male 'pill' is a figment of our scientific imagination or whether it will become a reality within the next 5 to 6 years.", 百拇医药