Guest guest Posted November 6, 2000 Report Share Posted November 6, 2000 In a message dated 00-11-06 23:35:47 EST, you write: << I really wonder if the fibroid shrinking benefit of this synthetic...I assume it is a synthetic hormone...is due to the fact that it makes the uterus EXPEL...how does it do this? Does it create contractions? If so, it could affect the blood supply to fibroids...does anyone know " WHY " the drug companies are saying this works? S >> I don't know the " why " but it's not the drug companies saying it works. There have been studies at the University of California (San Diego) in 1993 and the University of Rochester in 2000 that have established that the drug, which suppresses progesterone in the body, does indeed cause the fibroids to shrink. From what I've read and been told, it inhibits ovulation and stops a woman's periods; the only other side effects that have been mentioned are mild hot flashes and sometimes headaches. No contractions, no " expelling " from the uterus. The dosage in the trials was very small (25 mg, as opposed to the 600 mg used for abortions); once a woman stops taking it, her system returns to normal. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 7, 2000 Report Share Posted November 7, 2000 > In a message dated 00-11-06 23:35:47 EST, you write: > > << I really wonder if the fibroid shrinking benefit of this >synthetic...I assume it is a synthetic hormone...is due to the fact >that it makes the uterus EXPEL...how does it do this? Does it create >contractions? ***As I understand it, mifepristone does not make the uterus expel or contract, even in doses given for abortions. Another drug has to be given in order to make the uterus contract. The mifepristone obviously affects the uterine lining and the fibroids without causing either to be expelled. It obviously works, according to several studies done in university medical settings. dana Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 26, 2001 Report Share Posted January 26, 2001 Hi Carla, THIS is exactly what needs to happen. If enough of us will speak up something might change. Attached is the complete list of Inclusion & Exclusion criteria. I have copied this from an Excel spreadsheet - hope it is legible. INCLUSION CRITERIA: 1. Pre-menopausal and 18 years of age or older 2. Active symptoms of myomata and have a total myomatous or uterine size greater than or equal to 300 cc (myomatous volume defined by the sum of each myoma volume) 3. Meet ACOG guidelines for hysterectomy or myomectomy 4. Authorization of Release of Information by Primary care provider 5. Good general and mental health 6. Agree to abstain from sex or use non-hormonal contraception to prevent pregnancy EXCLUSION CRITERIA: 1. Pregnant or desire to become pregnant 2. Breast feeding 3. Adnexal masses or adnexal tenderness indicating further evaluation or surgery 4. Any of the following: Sickle cell anemia Adrenal disease Liver disease (severe) Respiratory disease (severe) Blood clotting defect 5. Exclusion medications Steroid medications Anticoagulants- such as Coumadin Hormones- such as estrogen, androgen, oral contraceptives or progestins forthree months, except Depo-provera. No use for six months of GnRH analogs,Danazol, and Depo-provera No use of herbal/botanical supplements with possible hormonal effects Herbal Supplements with Possible Female Hormonal Effects Dong quai ( sinensis) Black cohosh (Cimicifuga racemosa) Blue cohosh (Caulophyllum thalictroides) Chasteberry (Vitex agnus-castus) Licorice (Glycyrrhiza blabra) Life root (Senecio aureus or Senecio nemorensis) False unicorn root (Veratrum luteum) Saw palmetto (Serenoa repens) Soy isoflavones (phytoestrogens) Genistein Diadzein Glycetein ACOG Criteria for Myomectomy Procedure: Myomectomy Yes No Indication: Leiomyomata in infertility patients, as a probable factor in failure to conceive or in recurrent pregnancy loss 1. Presence of leiomyomata of sufficient size and specific location to be a probable factor ACOG Criteria for Hysterectomy for Leiomyomata Procedure: Hysterectomy, abdominal or vaginalYes No Indication: Leiomyomata Confirmation of Indication: Presence of 1 or 2 or 3 1. Asymptomatic leiomyomata of such size that they are palpable abdominally and are a concern to the patient 2. Excessive uterine bleeding evidenced by either the following: a) Profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days Anemia due to acute or chronic blood loss 3. Pelvic discomfort caused by myomata (a or b or c) a) Acute and severe Chronic lower abdominal or low back pressure c) Bladder pressure with urinary frequency not due to urinary tract infection Heleen Project Manager /Clinical Research Coordinator University of Rochester Medical Center 1000 South Avenue Rochester, New York 14620 Telephone: Fax E-mail Heleen_leroux@... mifepristone The major group to look to for information on how to become an activist re: RU-486 research is the Feminist Majority Foundation. They have been administering the compassionate use program for RU-486 in the U.S. and have been the organization footing the bill and doing all the work getting this drug approved. http://www.feminist.org <http://www.feminist.org> I would strongly urge you to forward your email to them (as well as your Congressional reps) so that your voice can be heard in Congress on this issue. Also, if you are interested in visiting Washington, D.C. in June to speak with your Congressional reps on this issue as well as others related to fibroid research, please email me offline. As for the study that you were unable to get into, could one of the researchers involved in RU-486 trials patient enrollment please identify more clearly any exclusionary factors for becoming a participant in a study to this list group so more women don't encounter a similar frustration with hanging their hat on getting into a study when it just may not be possible? Carla Dionne Executive Director National Uterine Fibroids Foundation mailto:carla@... http://www.NUFF.org <http://www.NUFF.org> /list/uterinefibroids </list/uterinefibroids> Personal email & website: mailto:cdionne@... http://www.uterinefibroids.com <http://www.uterinefibroids.com> " Never doubt that a small group of thoughtful committed citizens can change the world. Indeed it's the only thing that ever has. " Margaret Mead Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 26, 2001 Report Share Posted January 26, 2001 Hi Carla, THIS is exactly what needs to happen. If enough of us will speak up something might change. Attached is the complete list of Inclusion & Exclusion criteria. I have copied this from an Excel spreadsheet - hope it is legible. INCLUSION CRITERIA: 1. Pre-menopausal and 18 years of age or older 2. Active symptoms of myomata and have a total myomatous or uterine size greater than or equal to 300 cc (myomatous volume defined by the sum of each myoma volume) 3. Meet ACOG guidelines for hysterectomy or myomectomy 4. Authorization of Release of Information by Primary care provider 5. Good general and mental health 6. Agree to abstain from sex or use non-hormonal contraception to prevent pregnancy EXCLUSION CRITERIA: 1. Pregnant or desire to become pregnant 2. Breast feeding 3. Adnexal masses or adnexal tenderness indicating further evaluation or surgery 4. Any of the following: Sickle cell anemia Adrenal disease Liver disease (severe) Respiratory disease (severe) Blood clotting defect 5. Exclusion medications Steroid medications Anticoagulants- such as Coumadin Hormones- such as estrogen, androgen, oral contraceptives or progestins forthree months, except Depo-provera. No use for six months of GnRH analogs,Danazol, and Depo-provera No use of herbal/botanical supplements with possible hormonal effects Herbal Supplements with Possible Female Hormonal Effects Dong quai ( sinensis) Black cohosh (Cimicifuga racemosa) Blue cohosh (Caulophyllum thalictroides) Chasteberry (Vitex agnus-castus) Licorice (Glycyrrhiza blabra) Life root (Senecio aureus or Senecio nemorensis) False unicorn root (Veratrum luteum) Saw palmetto (Serenoa repens) Soy isoflavones (phytoestrogens) Genistein Diadzein Glycetein ACOG Criteria for Myomectomy Procedure: Myomectomy Yes No Indication: Leiomyomata in infertility patients, as a probable factor in failure to conceive or in recurrent pregnancy loss 1. Presence of leiomyomata of sufficient size and specific location to be a probable factor ACOG Criteria for Hysterectomy for Leiomyomata Procedure: Hysterectomy, abdominal or vaginalYes No Indication: Leiomyomata Confirmation of Indication: Presence of 1 or 2 or 3 1. Asymptomatic leiomyomata of such size that they are palpable abdominally and are a concern to the patient 2. Excessive uterine bleeding evidenced by either the following: a) Profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days Anemia due to acute or chronic blood loss 3. Pelvic discomfort caused by myomata (a or b or c) a) Acute and severe Chronic lower abdominal or low back pressure c) Bladder pressure with urinary frequency not due to urinary tract infection Heleen Project Manager /Clinical Research Coordinator University of Rochester Medical Center 1000 South Avenue Rochester, New York 14620 Telephone: Fax E-mail Heleen_leroux@... mifepristone The major group to look to for information on how to become an activist re: RU-486 research is the Feminist Majority Foundation. They have been administering the compassionate use program for RU-486 in the U.S. and have been the organization footing the bill and doing all the work getting this drug approved. http://www.feminist.org <http://www.feminist.org> I would strongly urge you to forward your email to them (as well as your Congressional reps) so that your voice can be heard in Congress on this issue. Also, if you are interested in visiting Washington, D.C. in June to speak with your Congressional reps on this issue as well as others related to fibroid research, please email me offline. As for the study that you were unable to get into, could one of the researchers involved in RU-486 trials patient enrollment please identify more clearly any exclusionary factors for becoming a participant in a study to this list group so more women don't encounter a similar frustration with hanging their hat on getting into a study when it just may not be possible? Carla Dionne Executive Director National Uterine Fibroids Foundation mailto:carla@... http://www.NUFF.org <http://www.NUFF.org> /list/uterinefibroids </list/uterinefibroids> Personal email & website: mailto:cdionne@... http://www.uterinefibroids.com <http://www.uterinefibroids.com> " Never doubt that a small group of thoughtful committed citizens can change the world. Indeed it's the only thing that ever has. " Margaret Mead Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 26, 2001 Report Share Posted January 26, 2001 Thanks Heleen. I also wanted to make a comment regarding the Right to Life's affirmation that they've never opposed other uses for mifepristone research. They are perfectly aware of the prevalence of " off-label " use of drugs and know full well that even if this drug were approved for other medical purposes (other than for abortion) that it would then be available to also be used as an abortificant. Although they indicated that they wouldn't oppose other uses of the drug, the reality is that they most definitely would lose control of this factor if it were approved for those other uses and not abortion. Once any drug is available for physicians to prescribe, there is little control over how or what it is prescribed for. So make no mistake, they oppose this drug from every angle possible in terms of making it legally available for physicians to prescribe and patients to use. As it stands right now, mifepristone is approved for abortion and, unless this changes with the current political forces that are in play, it should remain available for fibroid studies. To ensure positive progress on this front, it is imperative that members who are concerned begin writing their legislative reps today. Don't put it off. Do it today. Carla Dionne Executive Director National Uterine Fibroids Foundation mailto:carla@... http://www.NUFF.org /list/uterinefibroids Personal email & website: mailto:cdionne@... http://www.uterinefibroids.com " Never doubt that a small group of thoughtful committed citizens can change the world. Indeed it's the only thing that ever has. " Margaret Mead Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 26, 2001 Report Share Posted January 26, 2001 Thanks Heleen. I also wanted to make a comment regarding the Right to Life's affirmation that they've never opposed other uses for mifepristone research. They are perfectly aware of the prevalence of " off-label " use of drugs and know full well that even if this drug were approved for other medical purposes (other than for abortion) that it would then be available to also be used as an abortificant. Although they indicated that they wouldn't oppose other uses of the drug, the reality is that they most definitely would lose control of this factor if it were approved for those other uses and not abortion. Once any drug is available for physicians to prescribe, there is little control over how or what it is prescribed for. So make no mistake, they oppose this drug from every angle possible in terms of making it legally available for physicians to prescribe and patients to use. As it stands right now, mifepristone is approved for abortion and, unless this changes with the current political forces that are in play, it should remain available for fibroid studies. To ensure positive progress on this front, it is imperative that members who are concerned begin writing their legislative reps today. Don't put it off. Do it today. Carla Dionne Executive Director National Uterine Fibroids Foundation mailto:carla@... http://www.NUFF.org /list/uterinefibroids Personal email & website: mailto:cdionne@... http://www.uterinefibroids.com " Never doubt that a small group of thoughtful committed citizens can change the world. Indeed it's the only thing that ever has. " Margaret Mead Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 26, 2001 Report Share Posted January 26, 2001 Actually, this is the same issue that is problematic for me with the Women's Health Initiative study on HRT. http://www.nhlbi.nih.gov/whi/ My mom was in one of the HRT study groups (WAS - she withdrew herself) and so I called and asked for a copy of the WHI questionnaire and study plans. I was truly taken aback by the oversight of researchers on quite a few issues that would indeed impact study outcome. But I was more appalled by the questions that were NOT asked of my own mother regarding her medical history which, in my limited nonmedically trained opinion, should have precluded her from participation in any HRT trial. I've heard similar stories from others who were never asked about the OTC hormones they were taking and certainly not told to refrain from using them while on the WHI study. Too bad. Awfully big, awfully expensive study to have such oversights. I do know of women who are using a version of OTC progesterone who are in the calcium study. So, how will they know whether it's the calcium or something else that contributes to the documented outcome if they don't ask appropriate intake questions? Also, why are researchers underestimating the popular use of progesterone creams (and other OTC hormones) in the marketplace? Just curious cause I saw another intake questionnaire just today that was sent to me to review and comment on and the whole realm of OTC hormones was missing from the data collection questions on hormone use. Surprised me cuz this just seems like such a big oversight. Comments? Thoughts? carla "LeRoux, Heleen" wrote: Good question Elise - I will have to get back to you about that. RE: mifepristone Importance: High Hi Carla, THIS is exactly what needs to happen. If enough of us will speak up something might change. Attached is the complete list of Inclusion & Exclusion criteria. I have copied this from an Excel spreadsheet - hope it is legible. INCLUSION CRITERIA: 1. Pre-menopausal and 18 years of age or older 2. Active symptoms of myomata and have a total myomatous or uterine size greater than or equal to 300 cc (myomatous volume defined by the sum of each myoma volume) 3. Meet ACOG guidelines for hysterectomy or myomectomy 4. Authorization of Release of Information by Primary care provider 5. Good general and mental health 6. Agree to abstain from sex or use non-hormonal contraception to prevent pregnancy EXCLUSION CRITERIA: 1. Pregnant or desire to become pregnant 2. Breast feeding 3. Adnexal masses or adnexal tenderness indicating further evaluation or surgery 4. Any of the following: Sickle cell anemia Adrenal disease Liver disease (severe) Respiratory disease (severe) Blood clotting defect 5. Exclusion medications Steroid medications Anticoagulants- such as Coumadin Hormones- such as estrogen, androgen, oral contraceptives or progestins forthree months, except Depo-provera. No use for six months of GnRH analogs,Danazol, and Depo-provera No use of herbal/botanical supplements with possible hormonal effects Herbal Supplements with Possible Female Hormonal Effects Dong quai ( sinensis) Black cohosh (Cimicifuga racemosa) Blue cohosh (Caulophyllum thalictroides) Chasteberry (Vitex agnus-castus) Licorice (Glycyrrhiza blabra) Life root (Senecio aureus or Senecio nemorensis) False unicorn root (Veratrum luteum) Saw palmetto (Serenoa repens) Soy isoflavones (phytoestrogens) Genistein Diadzein Glycetein ACOG Criteria for Myomectomy Procedure: Myomectomy Yes No Indication: Leiomyomata in infertility patients, as a probable factor in failure to conceive or in recurrent pregnancy loss 1. Presence of leiomyomata of sufficient size and specific location to be a probable factor ACOG Criteria for Hysterectomy for Leiomyomata Procedure: Hysterectomy, abdominal or vaginalYes No Indication: Leiomyomata Confirmation of Indication: Presence of 1 or 2 or 3 1. Asymptomatic leiomyomata of such size that they are palpable abdominally and are a concern to the patient 2. Excessive uterine bleeding evidenced by either the following: a) Profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days Anemia due to acute or chronic blood loss 3. Pelvic discomfort caused by myomata (a or b or c) a) Acute and severe Chronic lower abdominal or low back pressure c) Bladder pressure with urinary frequency not due to urinary tract infection Quote Link to comment Share on other sites More sharing options...
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