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Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism
Plain-language guide to NCT04648969: phase 2 interventional trial of Kisspeptin-10, 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04648969
- Phase
- phase 2
- Status
- completed
- Start
- 2019-05-03
- Completion (planned or actual)
- 2025-08-31
- Participants
- 18 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hypogonadotropic Hypogonadism
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Kisspeptin-10.
The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
It had 1 arm (groups): Experimental: kisspeptin, GnRH (experimental).
• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.
The registry classes the interventions as drug.
More on the Plan
* Assignment: Each study subject will serve as their own control.
Who Took Part
Enrollment: 18 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 21 exclusion criteria; among the exclusions: age 18 years and older,; confirmed diagnosis of hh with; low testosterone or estradiol,.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Kisspeptin-10 study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2019-05-03 with completion listed for 2025-08-31.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin (time frame: 52 hours).
It also tracked 1 secondary outcome, for example Average Change in LH Pulse Frequency in Response to Kisspeptin.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Kisspeptin-10 in 18 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.