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Hypogonadotropic HypogonadismPhase 1NCT00914823

Kisspeptin Administration in the Adult

A Phase 1 study testing kisspeptin 112-121 and GnRH in people with Hypogonadotropic Hypogonadism and Kallmann Syndrome, 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
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Trial summary

The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body. Read more about this study

Who is it for?
Ages 18 years and olderHealthy 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
256 participants
Where
1 siteUnited States
Study dates
23 Jun 2009to 22 Oct 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult
  1. Healthy Subjects

All healthy subjects will meet the following criteria:

  • normal puberty with respect to onset and pace,
  • no chronic diseases,
  • no difficulty with blood draws,
  • no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy,
  • 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, at least 11 periods/year, with no more than 5 days variability in cycle duration,
  • no evidence for androgen excess (hirsutism or acne),
  • at screening, negative hCG pregnancy test,
  • negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study.
  1. Healthy postmenopausal women:
  • between 50 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:

  • 18 years or older,
  • all medical conditions stable and well controlled,
  • no prescription 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,
  • for women, at time of screening negative hCG pregnancy test.

Additional criteria based on subject population:

  1. Men and women with hypogonadotropic hypogonadism,
  • 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. Women with Polycystic Ovarian Syndrome (PCOS)
  • Confirmed diagnosis of PCOS,
  • If needed, additional labs and imaging tests may be performed.
  1. Men and women with hyperprolactinemia
  • confirmed diagnosis of elevated levels of prolactin measured via blood test,
  • no pituitary adenoma OR a microprolactinoma (<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded,
  • willing to complete a dopamine agonist washout.

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

Official title: Administration of Kisspeptin to Subjects With Reproductive Disorders

The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.

Read the detailed description

The reproductive hormone GnRH is essential for normal reproductive function. People with idiopathic hypogonadotropic hypogonadism (IHH), hyperprolactinemia, and polycystic ovarian syndrome (PCOS) do not secrete or respond to GnRH in a normal way. In this study, investigators will give participants kisspeptin-a hormone that is naturally found in the human body and is known to be a powerful stimulus of GnRH secretion. They may also give participants GnRH to determine if participants will be able to fully respond to kisspeptin. The goal of this study is to use kisspeptin administration to probe the condition of GnRH neurons in people with various reproductive disorders to better understand the underlying reasons for the disorders. Investigators hope to gain new insights into GnRH neuronal function (or dysfunction) that will lead to better diagnostics in the future.

Being tested
kisspeptin 112-121, GnRH
Keywords
reproductive disorders, kisspeptin, hypogonadotropic hypogonadism, Kallmann Syndrome, PCOS
Medical subject headings
Hypogonadism, Kallmann Syndrome, Polycystic Ovary Syndrome, Hyperprolactinemia

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

    One or more IV or SC doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121

  • GnRHDrug

    Also called gonadotropin-releasing hormone

    One or more IV doses of GnRH, and/or SC administration of GnRH

Study groups in NCT00914823
Study groupRoleWhat they receive
kisspeptin, GnRHExperimentalIntravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH
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 change in luteinizing hormone (LH) in response to kisspeptin

    Measured: Within 30 minutes of administration

Timeline

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

  1. First posted5 Jun 2009 (estimated)
  2. Study start23 Jun 2009
  3. Primary completion22 Oct 2021
  4. Study completion22 Oct 2021

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
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00914823
Sponsor's protocol ID
2008-P-002486
Status last verified
Jul 2024
First submitted
4 Jun 2009
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Galbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Davis JM, Miller KK, Carroll RS, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Intravenous kisspeptin 112-121 bolus does not acutely impact circulating vasopressin in humans. J Neuroendocrinol. 2026 Jan;38(1):e70114. doi: 10.1111/jne.70114. Epub 2025 Nov 22.

    PubMed 41273106

  • Galbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Carroll RS, Kim HK, Pereira SA, Paulis D, Davis JM, Miller KK, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Sex-dependent increases in oxytocin levels in response to intravenous kisspeptin in humans. Eur J Endocrinol. 2025 Mar 3;192(3):K24-K29. doi: 10.1093/ejendo/lvaf001.

    PubMed 39965102

  • Lippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146.

    PubMed 31132118

  • Chan YM, Lippincott MF, Butler JP, Sidhoum VF, Li CX, Plummer L, Seminara SB. Exogenous kisspeptin administration as a probe of GnRH neuronal function in patients with idiopathic hypogonadotropic hypogonadism. J Clin Endocrinol Metab. 2014 Dec;99(12):E2762-71. doi: 10.1210/jc.2014-2233.

    PubMed 25226293

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 Kallmann Syndrome, 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 31 Jul 2024. 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 change in luteinizing hormone (LH) in response to kisspeptin (time frame: Within 30 minutes of administration). 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 NCT00914823, 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 31 Jul 2024.

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