Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT05633966
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Sponsor:
Stephanie B. Seminara, MD
Organization:
Study Overview
Official Title:
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
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:
KASPR
Brief Summary:
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
Detailed Description:
Assignment: All study subjects will undergo the same interventions.
Delivery of Interventions:
* The subject will undergo a review of their medical history, physical exam, and screening laboratories.
* A pelvic ultrasound will be performed to assess baseline follicular size.
* A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
* During the course of kisspeptin administration, subjects will
* Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
* Undergo pelvic ultrasounds (approximately 4 sessions)
* Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin
Delivery of Interventions:
* The subject will undergo a review of their medical history, physical exam, and screening laboratories.
* A pelvic ultrasound will be performed to assess baseline follicular size.
* A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
* During the course of kisspeptin administration, subjects will
* Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
* Undergo pelvic ultrasounds (approximately 4 sessions)
* Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin
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?: