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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR MIFEPRISTONE

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Clinical Trials for Mifepristone

Trial ID Title Status Sponsor Phase Summary
NCT00001849 New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome Recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of ACTH in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as CT scans, MRIs, and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether [18-F]-fluorodeoxyglucose (FDG) or use of a higher dose of [111In-DTPA-D-Phe]-pentetreotide can be used to successfully localize the source of ectopic ACTH production.
NCT00043654 Clinical Trial of Mifepristone for Bipolar Depression Completed National Institute of Mental Health (NIMH) Phase 2 Bipolar Depression is a severe illness with high rates of psychiatric comorbidity and increased mortality related to suicide and medical illness. Hypothalamic pituitary axis (HPA) hyperactivity are found in bipolar disorder related to depression and mixed states. Patients with bipolar disorder also have cognitive difficulties and endocrine disturbances may contribute to such dysfunction. Antiglucorticoid therapies are novel treatments of mood disorder. Preliminary data in psychotic depression suggesting that mifepristone (RU-486), a glucocorticoid receptor antagonist, has antidepressant and salutary cognitive effects in a matter of days. In this study we examine the effects of mifepristone in severe bipolar depression in a parallel, double blind placebo controlled experiment. Bipolar subjects maintained on either lithium or valproate, after washout or prior antidepressants have a detailed neuroendocrine assessment. Patients approximately or almost 75 will receive eight days of mifepristone versus placebo after which patients are blindly crossed over to the opposite arm. Patients and a group of matched controls approximately or almost 35 will be compared with neuroendocrine, cognitive, and neurophysiologic testing to fully characterize their phenotype and explore biomarkers of response. It is hypothesized that stigmata of HPA axis hyperactivity and cognitive impairment will be predictive of response to antiglucocorticoid therapy with mifepristone.
NCT00044876 Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in premenopausal women. These tumors may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estrogen, medical therapies that decrease estrogen levels (like GnRH analog) cause fibroids to shrink and so may relieve symptoms. However, such medication can only be given short-term and has inconvenient side effects such as hot-flushes. Thus, many women with symptomatic fibroids choose to have them removed surgically, either individually or by removing the uterus via hysterectomy. The study evaluates a new medical treatment for fibroids using the progesterone receptor modulator CDB-2914. A similar compound, mifepristone (Registered Trademark), reduced fibroid size when given for twelve weeks. This study will compare fibroid size, hormone levels and symptoms before and during daily administration of CDB-2914 (10 or 25 mg) or placebo for 10 - 14 weeks. To do this, women will undergo MRI and a saline hysterosonogram (ultrasound with fluid) of the uterus before and at the end of the treatment; they will have blood drawn every 7 - 14 days, and will fill out a symptom calendar at home. Hysterectomy will be performed at the end of the treatment to evaluate the effects of the medication on the uterine and fibroid tissues, and to provide treatment for the study participant. Women will be randomly assigned to the treatment groups; during the treatment period neither the participants nor the investigators will know the type of treatment that a woman receives.
NCT00046553 Brain Receptor Function in Post-Traumatic Stress Disorder Completed National Institute of Mental Health (NIMH) N/A The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).
NCT00099645 Anti-HIV Activity and Safety of 3 Different Doses of Mifepristone in HIV Infected People Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 The purpose of this study is to determine the anti-HIV activity and safety of 3 different doses of mifepristone (also known as VGX-410 and RU486) in HIV infected people. Hypothesis: Mifepristone will be generally safe (no serious adverse effects) and well tolerated.
NCT00105105 Mifepristone as Adjunctive Therapy in Alzheimer's Disease Terminated Institute for the Study of Aging (ISOA) Phase 2 The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in patients with Alzheimer's disease (AD) who are also taking an acetylcholinesterase inhibitor (Aricept, Exelon or Reminyl).
NCT00105105 Mifepristone as Adjunctive Therapy in Alzheimer's Disease Terminated Corcept Therapeutics Phase 2 The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in patients with Alzheimer's disease (AD) who are also taking an acetylcholinesterase inhibitor (Aricept, Exelon or Reminyl).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mifepristone

Condition Name

Condition Name for Mifepristone
Intervention Trials
Abortion, Induced 12
Medical Abortion 6
Induced Abortion 5
Major Depressive Disorder 5
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Condition MeSH

Condition MeSH for Mifepristone
Intervention Trials
Depression 12
Depressive Disorder 11
Disease 10
Leiomyoma 10
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Clinical Trial Locations for Mifepristone

Trials by Country

Trials by Country for Mifepristone
Location Trials
United States 256
China 19
Vietnam 9
Georgia 7
Tunisia 7
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Trials by US State

Trials by US State for Mifepristone
Location Trials
California 29
New York 22
Pennsylvania 19
Illinois 19
Massachusetts 15
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Clinical Trial Progress for Mifepristone

Clinical Trial Phase

Clinical Trial Phase for Mifepristone
Clinical Trial Phase Trials
Phase 4 35
Phase 3 26
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Mifepristone
Clinical Trial Phase Trials
Completed 83
Recruiting 34
Terminated 14
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Clinical Trial Sponsors for Mifepristone

Sponsor Name

Sponsor Name for Mifepristone
Sponsor Trials
Gynuity Health Projects 31
Corcept Therapeutics 19
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 8
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Sponsor Type

Sponsor Type for Mifepristone
Sponsor Trials
Other 202
Industry 25
NIH 18
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Harvard Business School
US Army
Colorcon
Chinese Patent Office
Queensland Health
Medtronic
Dow
Chubb

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