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Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men
Plain-language guide to NCT03315325: phase 3 non-randomized trial of Kisspeptin-10, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03315325
- Phase
- phase 3
- Status
- completed
- Start
- 2014-08-08
- Completion (planned or actual)
- 2014-08-10
- Participants
- 15 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Sterility, Reproductive
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Kisspeptin-10.
It had three arms (groups): Adult men (experimental), Middle age men (experimental) and Advance age men (experimental).
The registry classes the interventions as biological.
More on the Plan
Little is known about the involvement of kisspeptin signalling in the causation of senescence-basal modulation of the GnRH-LH unit in any model and particularly in advance age men.
Who Took Part
15 actual participants took part.
It was open to men only aged from 25 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 0 inclusion and 10 exclusion criteria; among the exclusions: hepatic and renal complications; cardiovascular diseases; reproductive disorders.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Kisspeptin-10 study: the participants and staff both knew the treatment.
It started in 2014-08-08 with completion listed for 2014-08-10.
It ran at 1 site in Pakistan.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men. Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 30 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations. Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 60 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Kisspeptin-10 in 15 people.
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, 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.