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Sterility, ReproductivePhase 3NCT03315325

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

A Phase 3 study testing Human kisspeptin-10 (metastin 45-54) in people with Sterility, Reproductive, run by Quaid-e-Azam University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 25 to 75 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sterility, Reproductive
What is being tested?
Human kisspeptin-10 (metastin 45-54)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 sitePakistan
Study dates
8 Aug 2014to 5 Mar 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age

Who cannot join

  • Hepatic and renal complications
  • Epilepsy
  • Pneumonia
  • Asthma
  • Orchitis
  • Hernia
Show all 10Show fewer
  • Cryptorchidism
  • Cardiovascular diseases
  • Reproductive disorders
  • Mental retardation

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Quaid-i-Azam University

    Islamabad, 45320

Other trials in Pakistan

About this study

Official title: Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis to Kisspeptin-10 Administration in Men

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

Read the detailed description

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. The present study was therefore designed to assess the response of hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in healthy men. Sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). Kisspeptin-10 was administered (1 µg/kg BW) as an intravenous bolus, immediately after collecting 0 min sample to assess the response of GnRH neurons to kisspeptin-10 with increasing age in men by determining plasma levels of LH and testosterone.

Being tested
Human kisspeptin-10 (metastin 45-54)
Keywords
Aging
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

Study groups in NCT03315325
Study groupRoleWhat they receive
Adult menExperimentalThe 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.
Receives: Biological: Human kisspeptin-10 (metastin 45-54)
Middle age menExperimentalThe 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.
Receives: Biological: Human kisspeptin-10 (metastin 45-54)
Advance age menExperimentalThe 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.
Receives: Biological: Human kisspeptin-10 (metastin 45-54)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2017
  2. Study start8 Aug 2014
  3. Primary completion10 Aug 2014
  4. Study completion5 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Healthy men, 15 in number were selected. These individuals were classified on the basis of their ages in three groups: adult, middle age and advanced aged. Each group comprised of five participants.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03315325
Sponsor's protocol ID
Quaid-i-Azam University
Status last verified
Oct 2017
First submitted
30 Sep 2017
Last updated
23 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: After publishing will be available to all researchers. Additional data will be provided by the corresponding author on request.

Publications

  • Chan 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.

    PubMed 21470997

  • Dhillo WS, Chaudhri OB, Patterson M, Thompson EL, Murphy KG, Badman MK, McGowan BM, Amber V, Patel S, Ghatei MA, Bloom SR. Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males. J Clin Endocrinol Metab. 2005 Dec;90(12):6609-15. doi: 10.1210/jc.2005-1468. Epub 2005 Sep 20.

    PubMed 16174713

  • George JT, Veldhuis JD, Roseweir AK, Newton CL, Faccenda E, Millar RP, Anderson RA. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men. J Clin Endocrinol Metab. 2011 Aug;96(8):E1228-36. doi: 10.1210/jc.2011-0089. Epub 2011 Jun 1.

    PubMed 21632807

  • Jayasena CN, Nijher GM, Comninos AN, Abbara A, Januszewki A, Vaal ML, Sriskandarajah L, Murphy KG, Farzad Z, Ghatei MA, Bloom SR, Dhillo WS. The effects of kisspeptin-10 on reproductive hormone release show sexual dimorphism in humans. J Clin Endocrinol Metab. 2011 Dec;96(12):E1963-72. doi: 10.1210/jc.2011-1408. Epub 2011 Oct 5.

    PubMed 21976724

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human kisspeptin-10 (metastin 45-54) in people with Sterility, Reproductive, run by Quaid-e-Azam University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315325, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.

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