Re: Asoprisnil
From: Theresa (anonymous@obgyn.net)
Wed Mar 14 17:25:44 2007
I was in the all phases of the Asoprisnil studies. Towards the end,
issues of an unusual growth (the report implied cancerous) and a
thickened endometrium surfaced during one of the tests. My OBGYN also
noted unusually thickened lining and recommended a D&C. The study
doctor was condescending and suggested I be thankful that I had not had
a period for 3 years. He did not discuss the 'C' word with me. I had
to demand copies of each of the test results.
What is Tap trying to hide as they bring this drug to market? My husband
spoke with the researcher in Chicago to have him review my case or
transfer me to a respectful physician or allow my personal OBGYN to
complete the studies.
I was given another set of participation disclosures to sign with
numerous changes, exclusions, and an abreviated study term. Some of the
participants allegedly were diagnosed with thickened linings and one
with cancer. I have never been sick in my life, but my mother was a
colon cancer survivor. They say that stress increases the size of
fibroids...YEH!
Tap wanted me to do a 'clean out' which meant I would be off the drug
for 90 days. I further pressed for the D&C because my GYN said I would
bleed excessively with the first period. Te study doctor stated that
there typically was no period for the first two cycles after ceasing
Asoprisnil. Within days, I was flowing heavy and soaking a super pad
every 20 minutes. I lost hope when I attended a teachers luncheon and
barely got in the door before blood and fluid flowed down my legs to the
floor...I am not exaggerating.
My husband contacted TAP again and it was agreed that if an emergency
trip to the hospital was warranted, they would authorize the D&C.>>>BUT
they wanted me to try a rescue drug first to stop the bleeding -
Premerin! I agreed and that supposedly triggered my exit from the
program. Follow the doctors recommendations to stay in the program and
when they want you out to minimize costs, they compel you to take a drug
that boots you out.
My husband was infuriated at Taps callousness. After I was diagnosed
and had entered the program, he continued to do online research and came
across the writings of Dr. John Lee and Dr. Elizabeth Smith
(http://fibroid101.com/). I am doing better as to the length and
intensity of my periods, but the lining remains questionable. I am due
for my annual and am apprehensive that my GYN will order tests and a
D&C. I cannot afford this! Tap did authorize one test at my husband's
iinsistence; the fibroids were still there 90 days after I went off the
drug.
As to the consequences of being in the Asoprisnil Study: No periods for
3 years. Abnormally thickened lining - 29mm. Suspicion of cancerous
tumor that Tap refused to investigate and wasn't there during initial
trial testing. Inability to afford reasonable health insurance due to
study participation and label of having fibroidd - my initial premium
quote was raised 450% becasue I was honest and disclosed. I live in
fear, not knowing the impact Asoprisnil had on my health.
Participation guidelines specified that complete series of tests would
be conducted 6 months after exiting the study. I was informed they
would do no testing on me because I had violated the terms of the study
by taking the Premerin as recommended by the study doctor.
All hope is not lost: I have cleared all of the paraben based lotions,
cosmetics, & soaps from my bathroom. there are acceptable substitutes
and my husband finally got me into mineral make-up that does not contain
the parabens. I have lost 40 pounds and trying to lose another 20 to
minimize estrogen dominance. I have altered my diet completely with
very few processed foods on the menu.
If you are considering taking Asoprisnil, I caution you to research Dr.
Smith's website and read Dr. Lee's books on womens health as listed on
that website.
Good reading and success!
Theresa
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
>
--
Good reading and success!
Theresa (tn@mvms.biz)
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