Every single drug during the phase II testing since the 1990's must be tested in both genders and must have a gender analysis (unless it is for some body part only one gender has).Before th 1990's they usually only used men for all testing except for the things they didn't have the parts for.Drugs must be safe AND effective. Just because it doesn't hurt someone doesn't mean it gets approved. If a placebo is as effective or more effective the drug will not be approved.In the Phase II testing with both men and women it was statistically better than placebo in women but was not better than placebo for me.Since then some testing shows it may work for some men, but it would probably need a lot more than the few small studies to prove effectiveness to the point it would be approved.Drug testing phasesI. Small numbers of health people to see if it is even safe to give to anyone. Usually dozens of people. Make sure dose range is reasonably safe for humans.II. Test in hundreds of people with the disease to get initial idea if it can work and dose range it may work at.III. Test in a few thousand people with the disease to find the common side effects and check for efficacy. Can only test in subgroups where phase II show potential effectiveness.IV. Post release studies for any potential issues that come up.
I'm a male and after months of nagging got my GI to prescribe it to me. It is outrageously expensive ($700/month) so I got a free 15 or 20 day supply of it. Unfortunately I didn't see much of any benefit from it, it helped slightly with the urgency but no more then Imodium does. Some men see life changing results from taking it and others like myself see none. The only way to know is to try it out yourself. I see no reason why it would be any more dangerous for men to take than women.
My consultant told me that he had outstanding results in clinical trials with lotronex and particularly cilansetron for IBS D but a license was not approved for either in the UK.He said Cilansetron was extremely effective but us sufferers were denied a real breakthrough in the treatment options.The opinion of the regulators is that IBS is not serious enough!
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