Trial · Interventional
CompletedPhase 1Registry dataKisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Short name KASPR
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 13 participants (actual)
- Sponsor
- Stephanie B. Seminara, MD · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 16 Dec 2022
- Primary completion
- 31 Aug 2025
- Completion
- 31 Aug 2025
- First posted
- 1 Dec 2022
- Last update posted
- 3 Oct 2025
- Conditions
- Hypothalamic Amenorrhea · Hypogonadotropic Hypogonadism
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Kisspeptin 112-121Drug
Arms1
Experimental
Kisspeptin pump
SC administration of kisspeptin for two weeks (pulsatile)
Primary outcomes1
Outcomes the sponsor listed as primary.
The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
Time frame · 2 weeks
Registry description
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.
Secondary outcomes(1)
Change of luteinizing hormone (LH) pulse amplitude
Time frame · 2 weeks
Registry description
Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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