Kisspeptin Administration Subcutaneously to Patients With IHH

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT05896293
StatusRecruiting
PhasePhase 2
SponsorStephanie B. Seminara, MD
Enrollment36 participants
DesignInterventional, Na, Single Group, Masking: None
ConditionsHypogonadotropic Hypogonadism
Interventionskisspeptin 112-121; leuprolide acetate
StartFeb 3, 2023
Primary completionMay 2028
Study completionMay 2028
Results postedNot yet
Registry last updatedJul 13, 2026

Compounds on this site that cite this trial

What the registry says the trial is about

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.

Funding Source: FDA OOPD

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
Average change in luteinizing hormone (LH) pulse amplitude2 weeks

1 secondary outcome also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 30, 2026. See the trial changes feed for what has changed recently.