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Trial · Interventional

RecruitingPhase 2Registry data

Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

NCTNCT07224438 (opens ClinicalTrials.gov in a new tab)Other id565178Other idR37HD043341

Overview

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

United States

Start
9 Dec 2025
Primary completion
May 2030 (estimated)
Completion
May 2030 (estimated)
First posted
4 Nov 2025
Last update posted
13 Jul 2026
Conditions
Hypothalamic Amenorrhea · Hypogonadotropic Hypogonadism

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028202920302031
  1. Ph 2

    Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

    NCT07224438

    9 Dec 2025 to est. May 2030

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 women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.

Interventions

  • kisspeptin 112-121Drug

Arms1

  • Experimental

    Kisspeptin pump

    SC administration of kisspeptin for two weeks (pulsatile)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change of luteinizing hormone (LH) pulse amplitude

    Time frame · 2 weeks

    Registry description

    Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

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
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Female * Ages 18-45 years * Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism) * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg) * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women * Negative serum hCG pregnancy test * No current or recent use of a medication (including hormonal replacement) 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 its 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 * Pregnant * Trying to become pregnant during protocol participation * Breast feeding * History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

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