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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

Overview

Status
Completed
Phase
Phase 2
Enrollment
18 participants (actual)
Sponsor
Stephanie B. Seminara, MD · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
3 May 2019
Primary completion
31 Aug 2025
Completion
31 Aug 2025
First posted
2 Dec 2020
Last update posted
26 Aug 2026
Conditions
Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 2

    Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

    NCT04648969

    3 May 2019 to 31 Aug 2025

Registry summary

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

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

Interventions

  • kisspeptin 112-121Drug
  • GnRHDrug

Arms1

  • Experimental

    Experimental: kisspeptin, GnRH

    • Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin

    Time frame · 52 hours

    Registry description

    Change in LH amplitude before, during and after kisspeptin administration

Secondary outcomes(1)
  1. Average Change in LH Pulse Frequency in Response to Kisspeptin

    Time frame · 52 hours

    Registry description

    Change in LH frequency before and after kisspeptin administration

Posted results

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

Primary outcome results

Primary outcomeMean· 52 hours

Average Change in Luteinizing Hormone (LH) Pulse Amplitude in Response to Kisspeptin

GroupValue (IU/L)Spread
Experimental: Kisspeptin, GnRH0.350.43
Secondary and other outcome results(1)
Secondary outcomeMean· 52 hours

Average Change in LH Pulse Frequency in Response to Kisspeptin

GroupValue (# pulses/hour)Spread
Experimental: Kisspeptin, GnRH0.170.27

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Experimental: Kisspeptin, GnRH• Intravenous administration of kisspeptin 112-121; 20 boluses in a 40-hour period. Intravenous administration of GnRH; one bolus.0 / 181 / 186 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion/exclusion criteria: * Age 18 years and older, * Confirmed diagnosis of HH with * Low testosterone or estradiol, * Low or low-normal gonadotropin levels, * Thyroid stimulating hormone (TSH) and prolactin within the reference range, * Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI), * All other medical conditions stable and well controlled, * No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) 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, * No excessive alcohol consumption (\<10 drinks/week), * Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg), * White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range, * Prolactin below 110% of the upper limit of the reference range, * Hemoglobin * Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women, * Men: on adequate testosterone replacement therapy: normal male reference range, * Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated, * For women, * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration), * Not breastfeeding and not pregnant.

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