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Trial · Interventional

CompletedPhase 3Registry data

Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

Overview

Status
Completed
Phase
Phase 3
Enrollment
30 participants (actual)
Sponsor
Ghulam Nabi · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Pakistan

Start
26 Jun 2014
Primary completion
8 Aug 2014
Completion
5 Mar 2015
First posted
18 Sept 2017
Last update posted
18 Sept 2017
Conditions
Reproductive Physiological Phenomena

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 3

    Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

    NCT03286517

    26 Jun 2014 to 5 Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)Biological

Arms6

  • Experimental

    Tanner Stage I

    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.

  • Experimental

    Tanner Stage II

    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.

  • Experimental

    Tanner Stage III

    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.

  • Experimental

    Tanner Stage IV

    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.

  • Experimental

    Tanner stage V

    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.

  • Experimental

    Adult Group

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2018

6 results

Changes in the Responsiveness of the Hypothalamic-Pituitary-Gonadal Axis to Kisspeptin-10 Administration during Pubertal Transition in Boys.

Nabi et al. 2018International journal of endocrinologycited by 7

PMID 30046307PMC6038494DOI 10.1155/2018/1475967PUB-30046307

CC BY6 results

PubMed tag: none · 2011

7 results

The effects of kisspeptin-10 on reproductive hormone release show sexual dimorphism in humans.

Jayasena et al. 2011The Journal of clinical endocrinology and metabolismcited by 105

PMID 21976724PMC3232613DOI 10.1210/jc.2011-1408PUB-21976724

Rights unknown7 results

Indexing hint: Randomized controlled trial · 2009

7 results

Subcutaneous injection of kisspeptin-54 acutely stimulates gonadotropin secretion in women with hypothalamic amenorrhea, but chronic administration causes tachyphylaxis.

Jayasena et al. 2009The Journal of clinical endocrinology and metabolismcited by 149

PMID 19820030DOI 10.1210/jc.2009-0406PUB-19820030

Rights unknown7 results

Indexing hint: In vitro study · 2007

8 results

Kisspeptins are novel potent vasoconstrictors in humans, with a discrete localization of their receptor, G protein-coupled receptor 54, to atherosclerosis-prone vessels.

Mead et al. 2007Endocrinologycited by 96

PMID 17023533DOI 10.1210/en.2006-0818PUB-17023533

Rights unknown8 results

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Boys were classified into 5 different Tanner stages (I-V) according to the criteria of Feingold D. In Atlas of physical diagnosis. Pediatric endocrinology. 2nd ed. Philadelphia. WB Saunders; 1992, pp. 16-19. For comparison, adult men were also recruited. Exclusion Criteria: * Individuals with chronic illness or disorder, i.e. hepatic and renal complications, epilepsy, pneumonia, asthma, orchitis, hernia, cryptorchidism, mental retardation, etc. were excluded from this study

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