HypogonadismNCT00001412
Effects on the Brain of Lupron Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement
An observational study of Hypogonadism, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
There is evidence that suggests male sex hormones (androgens) play a significant role in brain (central nervous system) functioning. In studies conducted with animals, researchers have documented that male sex hormones (androgens) are associated with neurotransmitter (serotonin) function, sexual behavior, aggression… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1993to Nov 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Age 18-45.
Males.
No current mood symptoms.
No past psychiatric history.
Not taking ongoing medications.
No medical illnesses.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement
There is evidence that suggests male sex hormones (androgens) play a significant role in brain (central nervous system) functioning. In studies conducted with animals, researchers have documented that male sex hormones (androgens) are associated with neurotransmitter (serotonin) function, sexual behavior, aggression, and other non-reproductive behavior. Similar findings have been seen in studies involving humans.
Androgens are thought to be involved in some neurologic conditions. Tourette's syndrome which is seen more often in males than females has caused researchers to look more closely at the effects of androgens on the brain.
Read more
This study is designed to examine the effects of testosterone on brain (CNS) activity by first stopping testosterone release and then replacing it.
Researchers will evaluate mood, behavior, cognitive (mental) function, physiologic response to serotonergic agonists and regional cerebral blood flow (r-CBF).
This study will attempt to answer the following questions;
- Is a person's mental functioning a result of being male or female (gender) or a result of the hormonal condition
- Does the decrease of blood flow (r-CBF) to specific areas of the brain (prefrontal cortex) in women whose ovaries are not releasing hormones (hypogonadal state) also occur in men
- Will the mental rotation task better identify hormone (gonadal steroid) differences in r-CBF
- Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal (HPA) axis
- Does the hormonal state of a patient directly affect levels of chemicals and steroids in the cerebrospinal fluid (CSF).
Read the detailed description
Several types of evidence suggest that androgens exert clinically significant effects on central nervous system (CNS) function. In animal studies, androgens modulate brain serotonin function, and regulate sexual behavior, aggression, and other non-reproductive behaviors. These actions reflect both organizational and activational effects of androgens. Several studies in humans also support the central modulatory capacity of androgens. Correlative studies have described relationships between plasma androgen levels and sexual interest/behavior and cognitive task performance. Androgens are believed to underlie gender related differences in the prevalence of certain neuropsychiatric disorders, resulting in trials of anti-androgens in at least one of these disorders (Tourette's syndrome). Finally, androgens are believed to possess psychotropic effects in humans, evidenced by purported antidepressant effects and reports of psychotic reactions following administration of androgens. In a recent study, we demonstrated that androgenic/anabolic steroids precipitated mood and behavioral state disturbances when administered in a double-blind, placebo-controlled fashion in normal volunteers. There are remarkably few studies that attempt to identify the CNS effects of androgens or the central systems that may mediate these effects. In this study we propose to examine directly the effects of testosterone on CNS activity by first suppressing and then, in a double-blind, placebo-controlled fashion, replacing physiological levels of testosterone. We will evaluate mood, behavior, cognitive function, physiologic response to serotonergic agonists and cerebral blood flow (separate protocols) during both pharmacologically controlled hormonal conditions: hypogonadism and hypogonadism with testosterone replacement. 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 in women also demonstrable in men; 3) Do measures of hypothalamic-pituitary-adrenal axis responsivity differ as a function of gender or of hormonal condition; and 4) Do CSF neurochemistry and neurosteroid levels differ as a consequence of changing hormonal state. This protocol will not only provide much needed information about the behavioral and physiological effects of androgens but will serve as a companion study for NIMH protocol #92-M-172, "The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism with and without Estrogen and Progressive Replacement."
- Conditions
- Hypogonadism
- Keywords
- Gonadal Steroids, Central Nervous System Function, GnRH Agonist, Testosterone, Leuprolide Acetate, Mood, Behavior, Cognitive Function
- Medical subject headings
- Hypogonadism, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startDec 1993
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001412
- Sponsor's protocol ID
- 940037
- Other IDs
- 94-M-0037
- Status last verified
- Nov 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Rubinow DR, Schmidt PJ. Androgens, brain, and behavior. Am J Psychiatry. 1996 Aug;153(8):974-84. doi: 10.1176/ajp.153.8.974.
PubMed 8678193Handa RJ, Burgess LH, Kerr JE, O'Keefe JA. Gonadal steroid hormone receptors and sex differences in the hypothalamo-pituitary-adrenal axis. Horm Behav. 1994 Dec;28(4):464-76. doi: 10.1006/hbeh.1994.1044.
PubMed 7729815Su TP, Pagliaro M, Schmidt PJ, Pickar D, Wolkowitz O, Rubinow DR. Neuropsychiatric effects of anabolic steroids in male normal volunteers. JAMA. 1993 Jun 2;269(21):2760-4.
PubMed 8492402
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Testosterone Replacement
- ClinicalTrials.gov ID
- NCT00001412
- Acronym / sponsor ID
- 940037
- Conditions
- Hypogonadism
- Keywords
- Gonadal Steroids, Central Nervous System Function, GnRH Agonist, Testosterone, Leuprolide Acetate, Mood, Behavior, Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 1993
- Study completion
- Nov 2001
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is evidence that suggests male sex hormones (androgens) play a significant role in brain (central nervous system) functioning. In studies conducted with animals, researchers have documented that male sex hormones (androgens) are associated with neurotransmitter (serotonin) function, sexual behavior, aggression, and other non-reproductive behavior. Similar findings have been seen in studies involving humans.
Androgens are thought to be involved in some neurologic conditions. Tourette's syndrome which is seen more often in males than females has caused researchers to look more closely at the effects of androgens on the brain.
This study is designed to examine the effects of testosterone on brain (CNS) activity by first stopping testosterone release and then replacing it.
Researchers will evaluate mood, behavior, cognitive (mental) function, physiologic response to serotonergic agonists and regional cerebral blood flow (r-CBF).
This study will attempt to answer the following questions;
- Is a person's mental functioning a result of being male or female (gender) or a result of the hormonal condition
- Does the decrease of blood flow (r-CBF) to specific areas of the brain (prefrontal cortex) in women whose ovaries are not releasing hormones (hypogonadal state) also occur in men
- Will the mental rotation task better identify hormone (gonadal steroid) differences in r-CBF
- Do hormones directly influence the responsiveness of the hypothalamic-pituitary-adrenal (HPA) axis
- Does the hormonal state of a patient directly affect levels of chemicals and steroids in the cerebrospinal fluid (CSF).
Detailed description
Several types of evidence suggest that androgens exert clinically significant effects on central nervous system (CNS) function. In animal studies, androgens modulate brain serotonin function, and regulate sexual behavior, aggression, and other non-reproductive behaviors. These actions reflect both organizational and activational effects of androgens. Several studies in humans also support the central modulatory capacity of androgens. Correlative studies have described relationships between plasma androgen levels and sexual interest/behavior and cognitive task performance. Androgens are believed to underlie gender related differences in the prevalence of certain neuropsychiatric disorders, resulting in trials of anti-androgens in at least one of these disorders (Tourette's syndrome). Finally, androgens are believed to possess psychotropic effects in humans, evidenced by purported antidepressant effects and reports of psychotic reactions following administration of androgens. In a recent study, we demonstrated that androgenic/anabolic steroids precipitated mood and behavioral state disturbances when administered in a double-blind, placebo-controlled fashion in normal volunteers. There are remarkably few studies that attempt to identify the CNS effects of androgens or the central systems that may mediate these effects. In this study we propose to examine directly the effects of testosterone on CNS activity by first suppressing and then, in a double-blind, placebo-controlled fashion, replacing physiological levels of testosterone. We will evaluate mood, behavior, cognitive function, physiologic response to serotonergic agonists and cerebral blood flow (separate protocols) during both pharmacologically controlled hormonal conditions: hypogonadism and hypogonadism with testosterone replacement. 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 in women also demonstrable in men; 3) Do measures of hypothalamic-pituitary-adrenal axis responsivity differ as a function of gender or of hormonal condition; and 4) Do CSF neurochemistry and neurosteroid levels differ as a consequence of changing hormonal state. This protocol will not only provide much needed information about the behavioral and physiological effects of androgens but will serve as a companion study for NIMH protocol #92-M-172, "The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism with and without Estrogen and Progressive Replacement."
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8678193Rubinow DR, Schmidt PJ. Androgens, brain, and behavior. Am J Psychiatry. 1996 Aug;153(8):974-84. doi: 10.1176/ajp.153.8.974.
- Background: PubMed 7729815Handa RJ, Burgess LH, Kerr JE, O'Keefe JA. Gonadal steroid hormone receptors and sex differences in the hypothalamo-pituitary-adrenal axis. Horm Behav. 1994 Dec;28(4):464-76. doi: 10.1006/hbeh.1994.1044.
- Background: PubMed 8492402Su TP, Pagliaro M, Schmidt PJ, Pickar D, Wolkowitz O, Rubinow DR. Neuropsychiatric effects of anabolic steroids in male normal volunteers. JAMA. 1993 Jun 2;269(21):2760-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.