A Phase 1 interventional study of Kisspeptin 112-121 in Hypothalamic Amenorrhea and Hypogonadotropic Hypogonadism, sponsored by Stephanie B. Seminara, MD. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Stephanie B. Seminara, MD · Phase 1, Interventional, and Other
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.
Assignment: All study subjects will undergo the same interventions.
Delivery of Interventions:
During the course of kisspeptin administration, subjects will
345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.
This study's enrollment of 13 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.
Browse Hypogonadism studies →Stephanie B. Seminara, MD is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Acquired hypogonadotropic hypogonadism (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea)
Laboratory Studies:
Exclusion Criteria:
Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs
SC administration of kisspeptin for two weeks (pulsatile)
Drug: Kisspeptin 112-121
SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)
Also known as: metastin 45-54
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.
Time frame: 2 weeks
Change of luteinizing hormone (LH) pulse amplitude
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
Time frame: 2 weeks
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Stephanie B. Seminara, MD