A Phase 3 interventional study of Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) in Reproductive Physiological Phenomena, sponsored by Ghulam Nabi. Completed at 1 site in Pakistan. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Ghulam Nabi · Phase 3, Interventional, and Basic science
The specific objective of this study was to investigate the sensitivity of Kisspeptin receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma LH (luteinizing hormone) and testosterone concentrations.
No studies in humans are available regarding KISS1R signalling that, whether expression of the KISS1 or KISS1R sensitivity increases during the pubertal transition in boys. Kisspeptin regulates HPG (hypothalamic pituitary gonadal) axis by secreting GnRH that acts on the pituitary gonadotrophs to secrete LH and FSH. But in contrast to pubertal period, juvenile period kisspeptin pulsatility is reduced, that leads to low GnRH pulsatility and low level of plasma LH, FSH and testosterone. The objective of this study was to determine the response of exogenous kisspeptin in various juvenile stages up to puberty and also in the adults by measuring the level of plasma LH and testosterone. This study would help us to determine that whether there is any link between the increased sensitivity of kisspeptin signalling and puberty onset?, Or at what Tanner stage pre pubertal boys enter into puberty.
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This study's enrollment of 30 is below the median of 75 across 79 interventional studies indexed under Sexuality.
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A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 9.5 µg/BW.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 11.50 µg/BW.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 12.67 µg/BW.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 15.11 µg/BW.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 20.5 µg/BW.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 1 µg/kg.
Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
A neurohormone
To investigate the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma luteinizing hormone and testosterone concentrations
Time frame: A time frame for each individual was 3 hours. Kisspeptin-10 was injected intravenously and the blood samples were collected at 30 minutes intervals for 30 minutes pre and 2 hours post kisspeptin-10 injection through cannula.
Plan to share: Yes — Individual response to kisspeptin administration without disclosing the identity of an individual can be shared with other researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: I have already completed the study and can share the data. It will be available in the form of research paper along with the supplementary materials.
Access criteria: Will be available on journal website after publication or we can share personally.
Ran from Jun 2014 to primary completion in Aug 2014, 1 month.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: KISS1 protein, human