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Plain-language guide to NCT05901467: phase 1 interventional trial of Kisspeptin-10, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05901467
- Phase
- phase 1
- Status
- terminated early
- Start
- 2023-10-20
- Completion (planned or actual)
- 2024-05-29
- Participants
- 16 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Reproductive Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Kisspeptin-10.
The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.
It had 1 arm (groups): kisspeptin, GnRH (experimental).
IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.
The registry classes the interventions as drug.
More on the Plan
Assignment: All study subjects will undergo the same interventions.
Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility).
Who Took Part
16 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: No prescription medications that could interfere with hypothalamic reproductive function. No illicit drug use. No excessive alcohol consumption (more than 10 drinks/week). No history of an allergic medication reaction requiring emergency medical care. Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg).
The full record lists 15 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Kisspeptin-10 study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-10-20 with completion listed for 2024-05-29.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Primary outcome: Endogenous LH Pulse Amplitude (time frame: Hours 0-8). Kisspeptin-induced LH Pulse Amplitude (time frame: Hours 8-11).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Kisspeptin-10 in 16 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Kisspeptin-10 compound page, all human trials.
Our Notes on the Compound
Kisspeptin-10: A hypothalamic signaling peptide that triggers GnRH, and through it LH and FSH.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.