Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-28 @ 4:33 AM
Study NCT ID:
NCT00392457
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2006-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Regulation of Reproductive Hormones in Adult Men
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Organization:
Study Overview
Official Title:
Feedback Control of FSH Secretion in the Human Male
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
In the United States 10-15% couples seek evaluation for infertility, of whom a male factor is identified in approximately 50% of cases. To date, however, most infertility research has focused on the female partner and in the majority of instances the etiology of male infertility remains poorly understood with inconsistent elevation in FSH levels. Given that spermatogenesis is highly dependent on FSH secretion, this project will focus on delineating the feedback control of FSH in the human male. Such studies, although difficult to perform in the human, are critical to understanding not only the pathophysiology of male infertility, but also to determining the feasibility of hormonal approaches to male contraception. In this protocol, studies of normal, GnRH-deficient and agonadal men employing reversible sex steroid ablation, physiologic sex steroid replacement and manipulation of the GnRH input to the pituitary will permit the non-steroidal, sex steroid, and GnRH-dependent components of FSH regulation to be selectively elucidated.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HD015788 | NIH | None | https://reporter.nih.gov/quic… | View |