Current
Research
Breaking ground
in Cushing's research with...
"An Open Label Study of the Efficacy and Safety of CORLUX
(mifepristone) in the Treatment of the Signs and Symptoms of Endogenous
Cushing's Syndrome"
The SEISMIC
Study is a US based clinical research trial designed to examine
mifepristone in the treatment of the clinical manifestations of
endogenous Cushing's Syndrome over a 6 month period of treatment.
This study will enroll patients with Cushing's syndrome who have
not had effective results from surgery or radiation treatment. The
study may also enroll Cushing's patients who cannot undergo surgery
and who would still benefit from medical therapy. To qualify for
this study, your condition cannot be a result of having received
high doses of oral or injected drugs containing glucocorticoids
(e.g. prednisone or dexamethasone).
Other eligibility requirements are described on the SEISMIC
Study website.
For more information about the SEISMIC
Study, please email us at info@cushingsstudy.com
or call 1 877-367-6550 or visit the website www.cushingsstudy.com.
Back
to Top
Research Study
SOM230: A Phase III Study to
Assess the Safety and Efficacy of SOM230 in Patients with
Cushing's Disease
This Phase
III clinical research study is designed to investigate the effects
of an investigational medication (not approved by the Food and Drug
Administration), SOM230, in patients with active Cushing's disease.
Primary treatment for Cushing's disease is surgery to remove the
tumor causing elevated ACTH and cortisol levels. SOM230 may provide
an alternative medical treatment for patients with Cushing's disease.
Eligible adult subjects include ones that have confirmed diagnosis
of Cushing's disease, have not undergone radiation therapy for their
Cushing's within the last 2 years and and/or have not been cured
with surgery. There are 11 visits over six months of study participation.
Patients will receive SOM230 and study related procedures at no
charge. Those patients who receive benefit from this medication
will be offered enrollment in an open-label/extension study, where
SOM230 will be offered at no charge until it is approved by the
U.S. Food and Drug Administration. Additional information on this
study is available at www.novartisclinicaltrials.com (keyword: cushing)
and www.cushingsresearch.com.
The above study
is being conducted at multiple centers. To find the center closest
to you, you can check:
www.clinicaltrials.gov
or send an email through the Norvartis site at: http://www.novartisclinicaltrials.com
WOMEN WITH PITUITARY
PROBLEMS WANTED FOR A
TESTOSTERONE STUDY
Purpose:
Testosterone is the principal male sex hormone but is also present
in smaller amounts and may be important in women. Among its likely
actions in women are the building of bone and muscle mass, increase
in interest in sex (libido) and effects on the mood. The role of
testosterone replacement in women with low testosterone levels is
currently being studied. In this study, you will be given an experimental
preparation of a testosterone gel or placebo gel which will be applied
on the skin of your outer thigh for 6 months. It is anticipated
that this experimental gel application will produce levels of the
drug in the normal range for women. You will get the testosterone
gel for one year after the study, regardless of whether you were
on testosterone gel or placebo gel during the study. You will also
receive growth hormone without charge if it is determined that you
are growth hormone deficient.
The aim of
this study is to assess whether testosterone gel will improve body
composition, muscle strength, thinking and sexual function in female
patients with dysfunction of the pituitary gland. We will also carefully
record side effects related to testosterone. It is expected that
this study will determine if testosterone replacement is beneficial
in women with pituitary dysfunction.
Criteria for subjects:
- Women ages
18 to 55.
- Hypopituitarism
with documented central adrenal or gonadal deficiencies
- Serum testosterone
level of < 20 ng/dl or free testosterone <1.5 pg/ml (can
be tested at study site)
- Written
informed consent
- No other
significant medical condition
- Patients
must discontinue their current testosterone or DHEA replacement
Number
of patients-80
Location: King/Drew Medical Center in Willowbrook and UCLA
in West Los Angeles
Enrollment Period: 2004 and ongoing
Patient Compensation: $800
For more information or subject referrals contact:
Ted Friedman,
M.D., Ph.D. Clinical Director
Erik Zuckerbraun, M.D. Clinical Coordinator
Telephone (323) 563-9385
Email: study@goodhormonehealth.com
Fax: 323) 563-9324
Charles R. Drew University of Medicine and Sciences
1731 E. 120th St. Los Angeles, California 90059
Back
to Top
Research Study -
Mifepristone Symptomatic Treatment of Cushing's Syndrome Caused
by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion
Purpose:
Cushing's syndrome is caused sometimes by ectopic ACTH secretion.
If an ectopic tumor cannot be found or if surgery cannot be done,
medicines that reduce cortisol production can be given.
Mifepristone is a drug that blocks the action of cortisol in the
body. High daily doses of mifepristone have been used safely to
treat a few subjects with Cushing's syndrome as well as certain
kinds of cancer, gynecological diseases, and psychiatric disorders.
No major safety issues have been raised from these clinical studies.
In addition, mifepristone has been used safely in many countries
for more than ten years at a single dose of 600 mg to terminate
early pregnancy.
You will take
mifepristone by mouth three times a day. The dose of mifepristone
will be increased every week until you reach the highest dosage
allowed, or your symptoms are clearly improving. You will stay in
the hospital during this period. Thereafter, you will return to
the hospital every three months for the assessment of your condition.
You will be able to take mifepristone for up to 12 months if you
continue to do well. During the study period you will undergo physical
examination, electrocardiogram and a scan to measure body composition
intermittently, and you will fill out several standard questionnaires.
Blood will be drawn periodically to measure hormone levels and to
monitor the safety of mifepristone. If you are a woman, ultrasound
examinations of the uterine lining will be performed.
The aim of
this study is assess whether mifepristone will improve high blood
pressure, diabetes or other symptoms of Cushing's syndrome in subjects
with ectopic ACTH secretion.
Criteria
for admission into the study:
- Age 18
to 75 years
- Cushing's
syndrome caused by ACTH ectopic secretion confirmed biochemically
- Glucose
intolerance or diabetes and/or hypertension that is considered
to be caused or worsened by the hypercortisolism
- Women should
be sterilized, post-menopausal, sexually inactive or willing to
use barrier methods of contraception throughout the study.
- Subject
willing to return to NIH during the full course of the study
- No recent
changes in corrective treatments for diabetes, hypertension or
depression
- No severe
cardiovascular, liver or renal impairment
- Patients
must discontinue all approved or experimental steroidogenesis
inhibitors, adrenolytic agents or somatostatin analogues within
four weeks of admission
- Body weight
less than 136 kg
Number of
patients - 35
Location:
National Institutes of Health, Bethesda, Maryland
Enrollment
Period: 2007 and ongoing
For more
information or subject referrals contact:
Marina Zemskova,
M.D.
Telephone (301) 594-3385
Email: marinaz@mail.nih.gov
Fax: 301-402-0884
NIH/NIDDK-NICHD
10 Center Drive,
Room 6-3940
Bethesda, MD 20892
Back
to Top
Research Study - Rosiglitazone
Treatment of Cushing's Disease that have failed standard therapies/prior
to Pituitary Surgery
Purpose: No currently available medical treatment, both reduces
the excess hormones produced by Cushing's disease and tumor size.
We wish to examine the effects (good or bad) of rosiglitazone, a drug
treatment currently approved to treat diabetes on pituitary tumor
growth and hormone secretion. There are two separate studies. In the
first, called study 1, patients with newly diagnosed Cushings syndrome
due to a pituitary tumor will be seen by the doctor for a first visit
and then once a week for six weeks while taking rosiglitazone when
they are awaiting pituitary surgery. You will be asked to complete
a simple questionnaire regarding symptoms and undergo a basic physical
examination at each visit. You will be given a supply of the study
drug and a blood sample will be drawn at your first visit and every
2 weeks (approximately 6 times) and you will be asked to collect 24
hour urine collections for cortisol every week of the study (6 weeks),
to test effects of rosiglitazone on your cortisol levels. The second
study is similar in some respects but in study 2 we wish to examine
the effects of rosiglitazone in patients with Cushings syndrome who
have undergone at least one pituitary surgery. In study 2, our physicians
will see you for a first visit and then every month for a total of
6 months while taking rosiglitazone and you will be asked to complete
a simple questionnaire regarding symptoms and undergo a basic physical
examination at each visit. You will be given a supply of the study
drug, a blood sample will be drawn at your first visit and every 4
weeks (approximately 6 times), and you will be asked to collect 24
hour urine collections for cortisol every month (6 months). We will
also be carrying out some tests of your pituitary function. A pituitary
MR scan will be carried out at the start and at the completion of
the study to determine if the pituitary tumor has gotten smaller on
the drug treatment.
Criteria
for subjects:
- Male or
females; female patients must be either postmenopausal, and not
receiving hormone replacement therapy or of childbearing
potential, and practicing a medically acceptable method of birth
control.
- Age: 18-65
years
- Clinically
demonstrable ACTH-secreting tumor, evidence of biochemically active
disease, this includes elevated 24 hour urinary free cortisol
levels on at least 2 separate 24 hour urine collections a week
apart.
- Lack of
suppression of 0800h serum cortisol to <1.8 µg /dl following
administration of dexamethasone 1 mg at 11 pm the night before
and measurable plasma ACTH levels.
- Must have
a pituitary tumor demonstrated on MRI performed with and without
contrast
- Hypercortisolemic,
and does not wish to receive alternate steroid lowering therapy
such as ketoconazole and/or metryrapone.
- Must be
minimum of 1 month after any recent pituitary surgery (study 2
only)
Number of
patients:
15
Location:
UCLA- Principal
Investigator: Anthony Heaney, MD
UCLA-Harbor
Medical Center- Investigator: Christina Wang, MD
Enrollment
Period: 2006-2009
For more
information or subject referrals contact:
Shameka Faulkner,
Study Coordinator
Telephone
(310) 825-5874
Email:sfaulkner@mednet.ucla.edu
Fax: (310) 794-7654
Mailing
address:
David
Geffen School of Medicine at UCLA
900
Veteran ave, Warren Hall, Room 24-130
Los
Angeles, CA 90095
Back
to Top
Research Study -
Women With Pituitary Problems Wanted For a Testosterone Study
Purpose:
Testosterone is the principal male sex hormone but is also present
in smaller amounts and may be important in women. Among its likely
actions in women are the building of bone and muscle mass, increase
in interest in sex (libido) and effects on the mood. The role of
testosterone replacement in women with low testosterone levels is
currently being studied. In this study, you will be given an experimental
preparation of a testosterone gel or placebo gel which will be applied
on the skin of your outer thigh for 6 months. It is anticipated
that this experimental gel application will produce levels of the
drug in the normal range for women. You will get the testosterone
gel for one year after the study, regardless of whether you were
on testosterone gel or placebo gel during the study. You will also
receive growth hormone without charge if it is determined that you
are growth hormone deficient.
The aim of this study is to assess whether testosterone gel will
improve body composition, muscle strength, thinking and sexual function
in female patients with dysfunction of the pituitary gland. We will
also carefully record side effects related to testosterone. It is
expected that this study will determine if testosterone replacement
is beneficial in women with pituitary dysfunction.
Criteria for subjects:
- Women ages
18 to 55.
- Hypopituitarism
with documented central adrenal or gonadal deficiencies
- Serum testosterone
level of < 20 ng/dl or free testosterone <1.5 pg/ml (can
be tested at study site)
- Written
informed consent
- No other
significant medical condition
- Patients
must discontinue their current testosterone or DHEA replacement
Number of
patients - 80
Location:
King/Drew Medical Center in Willowbrook and UCLA in West Los Angeles
Enrollment
Period: 2004 and ongoing
Patient
Compensation: $800
For more
information or subject referrals contact:
Ted Friedman,
M.D., Ph.D. Clinical Director
Erik Zuckerbraun, M.D. Clinical Coordinator
Telephone (323) 563-9385
Email: study@goodhormonehealth.com
Fax: 323) 563-9324
Charles R. Drew University of Medicine and Sciences
1731 E. 120th St.
Los Angeles, California 90059
Back
to Top
National Institute
of Health
The National Institute of Health has ongoing research studies involving
Cushing's. If patients fit into an existing research protocol, evaluation
and treatment is free of charge. Interested patients or physicians
can call the NIH recruitment line at 800-411-1222.
Patients with
demonstrated high cortisol and no visible pituitary or ectopic tumor
may be eligible an imaging study being conducted by Dr. Lynette
Nieman - nieman@mail.nih.gov.
Pedriatic patients
with demonstrated high cortisol may be eligible for pedriatic studies.
Contact Meg Keil - keilm@cc1.nichd.nih.gov.
Clinical
Trials Data Base
The NIH also maintains a data base for NIH studies and those underway
at other centers.
www.clinicaltrials.gov.
Back
to Top
|
