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Dampening the Reproductive Axis With Continuous Kisspeptin
Plain-language guide to NCT05971849: phase 1 interventional trial of Kisspeptin-10, pcos, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05971849
- Phase
- phase 1
- Status
- completed
- Start
- 2023-10-06
- Completion (planned or actual)
- 2024-04-27
- Participants
- 8 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Reproductive Disorder; PCOS; Polycystic Ovary Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Kisspeptin-10 for pcos.
The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).
It had 1 arm (groups): kisspeptin (experimental).
IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.
The registry classes the interventions as drug.
More on the Plan
Assignment: All study subjects will undergo the same interventions.
Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.
Who Took Part
The registry lists 8 actual participants took part.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Ages 18-45 years. A history of clinical diagnosis of PCOS or equivalent clinical features. BMI \>18.5 and \<35 kg/m2. Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg). Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration.
The full record lists 13 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was 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 2023-10-06 with completion listed for 2024-04-27.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Primary outcome: Average change in LH pulse frequency (time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion). Average change in LH pulse amplitude (time frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Kisspeptin-10 in 8 people with pcos.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Kisspeptin-10 compound page, PCOS research.
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.