Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04648969
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2020-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Sponsor:
Stephanie B. Seminara, MD
Organization:
Study Overview
Official Title:
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Status:
COMPLETED
Status Verified Date:
2025-09
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 develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
Detailed Description:
* Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
* Delivery of Interventions:
* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
* On the day of the inpatient study, the subjects will
* Undergo q10 min blood sampling for 6 hours,
* Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
* Undergo q10 min blood samplings for another 6 hours,
* Receive a single GnRH IV bolus at hour 51.
* Delivery of Interventions:
* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
* On the day of the inpatient study, the subjects will
* Undergo q10 min blood sampling for 6 hours,
* Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
* Undergo q10 min blood samplings for another 6 hours,
* Receive a single GnRH IV bolus at hour 51.
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?:
False
Is an FDA AA801 Violation?: