AzTrials
AzTrials

Hypogonadotropic HypogonadismPhase 1NCT01438073

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

A Phase 1 study testing kisspeptin 112-121 and GnRH in people with Hypogonadotropic Hypogonadism and Healthy Postmenopausal Women, run by Massachusetts General Hospital at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
kisspeptin 112-121 and GnRH
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited States
Study dates
Sep 2011to Apr 2016
Phase
Phase 1
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult
  1. Healthy Subjects

All healthy subjects will meet the following criteria:

  • normal puberty with respect to onset and pace,
  • no difficulty with blood draws,
  • no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
  • no illicit drug use or excessive alcohol consumption (>10 drinks/week),
  • no history of a medication reaction requiring emergency medical care,
  • normal physical exam and laboratory studies within protocol reference ranges.

Additional criteria based on subject population:

  1. Healthy Men:
  • between 21 and 40 years old,
  • normal erectile and ejaculatory function, no history of reproductive disorders,
  • testicular volume >15 ml.
  1. Healthy women:
  • between 21 and 40 years old,
  • not breastfeeding or pregnant,
  • menstrual cycles between 25 and 35 days in duration with no more than 5 days variability in cycle duration,
  • no evidence for androgen excess (hirsutism or acne),
  1. Healthy postmenopausal women:
  • between 48 and 60 years old,
  • no menstrual periods within the last year,
  • previous history of menstrual cycles between 25 and 35 days in duration, with no more than 5 days variability in cycle duration,
  • if applicable, able to undergo washout from hormone therapy,
  • no evidence for androgen excess (hirsutism or acne),
  • negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study.
  1. Subjects with Reproductive Disorders

All subjects with reproductive disorders will meet the following criteria:

  • all medical conditions stable and well controlled, medications allowed include asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication,
  • no medications known to affect reproductive endocrine function for at least 2 months except for medications used to treat the subject's reproductive condition,
  • no history of a medication reaction requiring emergency medical care,
  • no illicit drug use or excessive alcohol consumption (>10 drinks/week),
  • for women, not breastfeeding or pregnant,
  • if applicable, able to undergo appropriate washout from hormone therapy,
  • normal physical exam and laboratory studies within protocol reference ranges,

Additional criteria based on subject population:

  1. Men and women with hypogonadotropic hypogonadism,
  • 18 years or older,
  • Confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins,
  • If needed, additional labs and imaging tests may be performed.
  1. Agonadal men,
  • Between 18 and 60 years old.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

Read the detailed description

Please contact study staff for a detailed description.

Being tested
kisspeptin 112-121, GnRH
Medical subject headings
Hypogonadism, Gonadal Dysgenesis

What participants receive

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

  • kisspeptin 112-121Drug

    Also called metastin 45-54

    24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg)

  • GnRHDrug

    Also called gonadotropin-releasing hormone

    Single intravenous dose of GnRH (2.5-250 ng/kg)

Study groups in NCT01438073
Study groupRoleWhat they receive
kisspeptin, GnRHExperimental24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)
Receives: Drug: kisspeptin 112-121; Drug: GnRH

What is being measured

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

  1. Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion

    Measured: 24 hours

Secondary outcomes (2)

  1. Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males)

    Measured: 24 hours

  2. Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females)

    Measured: 24 hours

Timeline

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

  1. First posted21 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2016
  4. Study completionApr 2016

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 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01438073
Sponsor's protocol ID
2011-P-001564
Status last verified
Jul 2022
First submitted
24 Aug 2011
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Naveed A, Lippincott MF, Stamou M, Balasubramanian R, Bryant NK, Seminara SB. Dynamic modulation of LH secretion by continuous kisspeptin infusion in healthy men. Hormones (Athens). 2026 Jun 2:10.1007/s42000-026-00795-y. doi: 10.1007/s42000-026-00795-y. Online ahead of print.

    PubMed 42230485

  • Lippincott MF, Chan YM, Rivera Morales D, Seminara SB. Continuous Kisspeptin Administration in Postmenopausal Women: Impact of Estradiol on Luteinizing Hormone Secretion. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2091-2099. doi: 10.1210/jc.2016-3952.

    PubMed 28368443

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing kisspeptin 112-121 and GnRH in people with Hypogonadotropic Hypogonadism and Healthy Postmenopausal Women, run by Massachusetts General Hospital at 1 site in United States.

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

Who may be eligible to take part?

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 11 Jul 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion (time frame: 24 hours). 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 NCT01438073, which also lists 2 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 11 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in