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 number | NCT05896293 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stephanie B. Seminara, MD |
| Enrollment | 36 participants |
| Design | Interventional, Na, Single Group, Masking: None |
| Conditions | Hypogonadotropic Hypogonadism |
| Interventions | kisspeptin 112-121; leuprolide acetate |
| Start | Feb 3, 2023 |
| Primary completion | May 2028 |
| Study completion | May 2028 |
| Results posted | Not yet |
| Registry last updated | Jul 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 measure | Time frame |
|---|---|
| Average change in luteinizing hormone (LH) pulse amplitude | 2 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.
More trials of Kisspeptin-10
- Kisspeptin-10 and GnRH: Phase 2 Trial (NCT04648969)
- TAK-448: Phase 2 Trial (NCT02369796)
- Kisspeptin-10: Phase 1 Trial (NCT05633966)
- Kisspeptin-10 and GnRH: Phase 1 Trial (NCT01438073)
Research area: Sexual health and melanocortin. Every registered trial we follow is in the clinical trial tracker, and the labels used on this page are explained in our evidence standards.