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Re: AsoprisnilFrom: Mary (anonymous@obgyn.net)Mon Oct 24 07:44:34 2005
At Fri, 20 Aug 2004, Anne wrote: > >At Mon, 9 Aug 2004, Jean wrote: >> >>At Mon, 9 Aug 2004, AndreaW wrote: >>> >>>At Fri, 30 Jul 2004, Anne wrote: >>>> >>>>At Thu, 3 Jun 2004, Jean wrote: >>>>> >>>>>Has anyone been able to try Asoprisnil (a selective progesterone >>>>>receptor modulator) for endo or fibroids? I think it may still only be >>>>>available in clinical trials. I've heard that it usually stops your >>>>>period while you're on it, with minimal side effects? I'd be interested >>>>>to hear about anyone's experience with it. >>>>> >>>>>-- >>>>>Jean >>>>> >>>>Jean, >>>>I too have been very excited about this promising investigative drug. So >>>>far it has has tested better than RU-486 in that it does not cause >>>>overgrowth of the endometruim and androgenic side effect. It also does >>>>not cause loss of bone density like Lupron (also TAP's drug), so can be >>>>taken long-term. It is in phase II trails for endo and phase III for >>>>fibroids. >>>>I have fibroids but already am symptomatic with inability to urinate if >>>>I let my bladder get too full, so, if my fibroids continue to grow I >>>>don't know if I can avoid surgery before this drug is approved. >>>> >>>>According to TAP labs it will be submitted to the FDA for approval in >>>>2005, so expect it to be approved by the end of 2006 for fibroid >>>>treatment. Endo approval would probably be about a year later. >>>> >>>>If you can hang in there a few more years you might try this then. >>>> >>>>I would really like to hear from women who have been involved in the >>>>clinical trials what their experiences with any side effects were/are, >>>>since that is why I am basically scared to death of Lupron and looking >>>>for the next best drug therapy. >>>> >>>>To the doctors- what is the buzz on this drug in your circles? >>>> >>>>-- >>>>Anne >>>> >>>-- >>>I am on the clinical study for Asoprisnil because of fibroids. It is wonderful. The study is a blind study with the possibility of being on a placebo. I have no idea what dosage I am on (there were more than one dosage being tested). I started in October and have not had a period since. As of May of this year, my fibroid has shrunk by approximately 25%. I am on a study extension. The original study was for 6 months, I am on for an additional 12 months. I just went in today for study visit. This is the BEST I have felt in the last 2 or 3 years! From my visit today, they were saying that I may be able to continue on the medication after the study until the drug is approved and available. >>> >>>Is there no one in your area doing the study? Can your doctors find out who in your area is doing the study? My clinical research center is in Tampa, FL with Insignia Care for Women. >>> >>>As for side effects, I have not noticed any. > >Andrea, >Oooooooh I am so envious of you! So the phase III trial started a little >later than planned? But still, it is closed so I can't get in. I am >managing my symptoms for now and really hoping to avoid both surgery and >Lupron. But I suppose I will try Lupron if I have to take action before >Asoprisnil is available. Thank you for sharing your experience. > >Can't wait to see a vast reduction in unnecessary hysterectomys and >surgeries performed on so many women each day just to remove these >stupid benign growths! > >Kudos to TAP labs :) > >-- >Anne > >>I went to my current gynecologist because he had an ad in for the >>Asoprisnil study. I was desperate for something that would help my 3-4 >>days/month of excruciating pain, which I think is due to endo, but I >>knew I also had a fibroid so, what the heck? I figured it would probably >>help with the endo, too. Well, that led into a year-long ovarian cancer >>scare because when they were working me up for the Asoprisnil study they >>found something on my left ovary that looked suspicious. This >>disqualified me from the study. I refused exploratory surgery that >>everyone said was mandatory. More than a year later I'm still here, not >>sick, and the "thing" on the ovary has not changed, gotten bigger, or >>anything suspicious looking. My CA-125 went down (they took the first >>one, which was elevated, when I was still bleeding). Now I'm going to >>have my first laparoscopy on August 18th, to look around -- I suspect >>this is going to reveal high endo and adhesions. The only other >>procedure I've had before is a D&C two years ago, so this is kind of >>nerve wracking. I have this fantasy that afterward he says "well, you >>look like you could use some Asoprisnil, and I'm about to start a new >>trial" ... yeah, right! Maybe I will get some answers, though. >> >>-- >>Jean > >I'm sorry you missed the trial too, Jean. How did your laproscopy go? > >Anne >
-- I am in Phase 3 of the Asoprisnil study. The medication is wonderful. It has shrunk my fibroid tumor considerably, and I have not had a period for 3 years!! BUT, I was notified by my study Nurse last week that they are dicontinuing the study. I was very disappointed about this. Why would they discontinue this study when the drug is the answer to a hysterectomy?? I'm just wondering if anyone else has been told this same thing. I was told that once the drug was FDA approved, then I would receive 1 year free. Now I don't know what is going to happen. I am supposed to see my study Doctor within 2 weeks and then I will have to stop taking the drug. Please let me know if any of you have been told this same thing.
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