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Trial · Interventional

RecruitingPhase 2Registry data

Kisspeptin Administration Subcutaneously to Patients With IHH

NCTNCT05896293 (opens ClinicalTrials.gov in a new tab)Other idFD007843
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
3 Feb 2023
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
First posted
9 Jun 2023
Last update posted
13 Jul 2026
Conditions
Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026202720282029
  1. Ph 2

    Kisspeptin Administration Subcutaneously to Patients With IHH

    NCT05896293

    3 Feb 2023 to est. May 2028

Registry summary

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

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD

Interventions

  • kisspeptin 112-121Drug
  • leuprolide acetateDrug

Arms1

  • Experimental

    kisspeptin pump

    SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average change in luteinizing hormone (LH) pulse amplitude

    Time frame · 2 weeks

    Registry description

    Average difference in LH amplitude after the first dose of kisspeptin (day 1) compared to the last dose of kisspeptin (day 15)

Secondary outcomes(1)

  1. Percentage of female participants who demonstrate achievement of a mature follicle or show evidence of ovulation

    Time frame · 2 weeks

    Registry description

    Percentage of female participants that develop a mature follicle or ovulate. Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level.

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.

A trial that is still running, or that stopped early, may post results later.

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 Criteria: * Congenital IHH * Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and method of administration * If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug Exclusion Criteria: * Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol * Excessive alcohol consumption (\>10 drinks/week) * Active use of illicit drugs (not including marijuana) * For women: * Pregnant or trying to become pregnant * Breast feeding * History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

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