Hypogonadism Clinical Trial
Official title:
Feedback Control of FSH Secretion in the Human Male
The purpose of the research study is to learn more about the regulation of reproductive
hormones in adult men. We would like to understand what role testosterone and estradiol play
in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating
hormone). Testosterone and estradiol come from the testes, and LH and FSH are released from
a gland in the head called the pituitary.
Men involved in the study will have detailed evaluations that involve overnight stays in the
hospital and frequent blood sampling. The men in the study will also be receiving
medications that affect the levels of various hormones in the body. This will allow the
researchers to learn how various hormones influence each other. Men that participate in the
study will receive medical evaluations and monetary compensation. Information gathered from
this study will help in the development of new treatments for infertility and potentially
new hormonal forms of contraception.
Status | Completed |
Enrollment | 175 |
Est. completion date | February 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Men aged 18 to 50 years - In good health - On no medications Exclusion Criteria: Subjects will not be enrolled in this study if there is a history of: - Liver disease or if screening blood tests demonstrate abnormal liver function tests - Excessive alcohol consumption - Illicit drug use - Severe drug allergy - Use of any concomitant medications - Peptic ulcer disease or gastritis |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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* Note: There are 25 references in all — Click here to view all references
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Primary | serum hormone levels | Baseline, Day 3, and Day 6 | No |
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