Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT04975334
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Antagonism in Hypogonadotropic Hypogonadism
Sponsor:
Stephanie B. Seminara, MD
Organization:
Study Overview
Official Title:
Opioid Antagonism in Hypogonadotropic Hypogonadism
Status:
COMPLETED
Status Verified Date:
2025-12
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 goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
Detailed Description:
Assignment: Each study subject will serve as their own control.
Delivery of Interventions:
* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the study, the subjects will undergo the following:
* Undergo q10 min blood sampling for 3 hours
* Receive a naloxone bolus at the midpoint of q10 min sampling
Delivery of Interventions:
* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the study, the subjects will undergo the following:
* Undergo q10 min blood sampling for 3 hours
* Receive a naloxone bolus at the midpoint of q10 min sampling
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: