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Trial · Interventional

CompletedPhase 3Registry data

Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

NCTNCT03315325 (opens ClinicalTrials.gov in a new tab)Other idQuaid-i-Azam University
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
15 participants (actual)
Sponsor
Quaid-e-Azam University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Pakistan

Start
8 Aug 2014
Primary completion
10 Aug 2014
Completion
5 Mar 2015
First posted
20 Oct 2017
Last update posted
23 Oct 2017
Conditions
Sterility, Reproductive

Timeline

1 trial · 1 completed

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

    Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

    NCT03315325

    8 Aug 2014 to 5 Mar 2015

Registry summary

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

The present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

Interventions

  • Human kisspeptin-10 (metastin 45-54)Biological

Arms3

  • Experimental

    Adult men

    The average age was 25.80±0.37 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

  • Experimental

    Middle age men

    The average age was 47.00±0.77 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

  • Experimental

    Advance age men

    The average age was 73.20±0.91 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men

    Time frame · Two blood samples at 30 minutes interval before kisspeptin injection were obtained from all the groups to determine basal levels for LH and testosterone.

  2. 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

    Time frame · One blood sample from all individuals were obtained after 30 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

  3. 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

    Time frame · One blood sample from all individuals were obtained after 60 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

  4. Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 90 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations

    Time frame · One blood sample from all individuals were obtained after 90 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

  5. Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 120 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations

    Time frame · One blood sample from all individuals were obtained after 120 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

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

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Clinical trial · 2011

7 results

Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men.

George et al. 2011The Journal of clinical endocrinology and metabolismcited by 127

PMID 21632807PMC3380939DOI 10.1210/jc.2011-0089PUB-21632807

Rights unknown7 results
Source linkSee results (7)

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
Source linkSee results (7)

Indexing hint: Randomized controlled trial · 2005

6 results

Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males.

Dhillo et al. 2005The Journal of clinical endocrinology and metabolismcited by 472

PMID 16174713DOI 10.1210/jc.2005-1468PUB-16174713

Rights unknown6 results
Source linkSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultChan YM, Butler JP, Pinnell NE, Pralong FP, Crowley WF Jr, Ren C, Chan KK, Seminara SB. Kisspeptin resets the hypothalamic GnRH clock in men. J Clin Endocrinol Metab. 2011 Jun;96(6):E908-15. doi: 10.1210/jc.2010-3046. Epub 2011 Apr 6. PMID 21470997

Eligibility

Who could join, as posted.

Sex
Male
Age
from 25 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: • Age Exclusion Criteria: * Hepatic and renal complications * Epilepsy * Pneumonia * Asthma * Orchitis * Hernia * Cryptorchidism * Cardiovascular diseases * Reproductive disorders * Mental retardation

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