|
The Effects of Reproductive Hormones on Brain Function Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on The Effects of Reproductive Hormones on Brain Function conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Effects of Reproductive Hormones on Brain Function Clinical research trials and The Effects of Reproductive Hormones on Brain Function health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like The Effects of Reproductive Hormones on Brain Function. The Effects of Reproductive Hormones on Brain Function Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a The Effects of Reproductive Hormones on Brain Function clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their The Effects of Reproductive Hormones on Brain Function condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Effects of Reproductive Hormones on Brain Function  The Effects of Reproductive Hormones on Brain Function
The Effects of Reproductive Hormones on Brain Function
For Condition: Hypogonadism
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to evaluate the effect of the hormones progesterone and estrogen on women's mood, behavior, and mental functioning. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
Details: Evidence suggests that the gonadal steroids may exert clinically significant effects on central nervous system function. For example, the menstrual cycle may influence the occurrence of seizures in some female epileptics and the performance on certain cognitive tests. Central nervous system effects of gonadal steroids have been inferred largely from changes in behavior occurring in association with presumed changes in gonadal steroids during the normal menstrual cycle, during the administration of ovarian hormones, or in a gender-specific context. These inferences are, by definition, indirect and associational in nature and further are incapable of disentangling the effects of hormones which are simultaneously present in women of reproductive age. This study is designed to address those problems by comparing measures during Lupron-induced hypogonadism with those during replacement with estrogen or progesterone. On the basis of prior findings from our group and from others, we will be asking the following questions: 1) Does cognitive function differ as a function of gender or of hormonal condition; 2) Is the decreased r-CBF that we observed in the prefrontal cortex during the hypogonadal state confirmed in individual women using new imaging techniques; 3) Will the mental rotation task, a sexually dimorphic cognitive task, better identify gonadal steroid related differences in brain r-CBF than tests of working memory; and 4) Do measures of hypothalamic-pituitary-adrenal axis responsivity differ as a function of hormonal condition. Additionally, this protocol will serve as a control study for protocol # 90-M-0088 and a companion protocol for 94-M-0037.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA Between the ages of 18 and 45. Subjects who are not pregnant. Must be in good health. Must be medication free. EXCLUSION CRITERIA Subjects taking birth control pills or diuretics. Patients taking psychotropic agents (e.g., lithium carbinate, tricyclic antidepressants). Controls must not have current or past axis I psychiatric diagnosis. Must not have a history of menstrual-related mood or behavioral disturbances.
Total Enrollment: 90
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Linda Clair 3014969576
Additional Information:
Study ID Numbers: 920174; 92-M-0174
Study Start Date: April 25, 1992
Record last reviewed: April 29, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001322
Other Hypogonadism Studies:
1. Leuprolide in Determining the Cause of Gonadotropin Deficiency
2. The Effects of Reproductive Hormones on Brain Function
3. Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism with and without Testosterone Replacement
4. Leuprolide in Treating Adults With Hypogonadotropism
5. Prevention of Osteoporosis in Men with Prostate Cancer
Related Studies:
Other Hypogonadism Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Effects of Reproductive Hormones on Brain Function
|
|
|
|
|
|
|
|
